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# Katrina Rogers Consulting

News and Commentary on the science and technology of drugs and medical devices, including discovery, development, manufacturing, and regulation.

## Sitemaps

- [XML Sitemap](https://krogersconsulting.com/sitemap.xml): Contains all public & indexable URLs for this website.

## Posts

- [Join me on Substack](https://krogersconsulting.com/business/join-me-on-substack/) - I'm excited to invite you to join me on Substack, where I'm building a dynamic community of leaders, innovators, and changemakers.
- [Make or Buy? Outsourcing as a Strategic Choice](https://krogersconsulting.com/product-development/make-or-buy-outsourcing-as-a-strategic-choice/) - Strategic outsourcing practices allow access to specialized services that can be expensive to establish and maintain as in-house departments.
- [Are Your Financials Ready for a Series Raise? Interviews with the Experts](https://krogersconsulting.com/leadership/are-your-financials-ready-for-a-series-raise/) - Startup expert discusses series raise challenges, emphasizing the need for strong financial documentation when transitioning from Angel to Series rounds.
- [Four Points of Startup Readiness](https://krogersconsulting.com/leadership/four-points-of-startup-readiness/) - I speak with many startup founders every week. Most work in drugs, medical devices, diagnostic tests, or digital health tools.
- [Understanding Dilutive Funding – Part 2](https://krogersconsulting.com/business/understanding-dilutive-funding-part-2/) - This month, we examine dilutive funding in a two-part series. Part 1 describes dilutive financing in general terms and reviews the available funding stages.
- [Understanding Dilutive Funding – Part 1](https://krogersconsulting.com/business/understanding-dilutive-funding-part-1/) - Last month, I reviewed non-dilutive funding sources in a two-part article. This month, we’ll turn to the subject of dilutive funding in a two-part blog series.
- [Katrina’s Reading List](https://krogersconsulting.com/leadership/katrinas-reading-list-2024/) - I’ve been pleasantly surprised by my reader’s response to previous book recommendations and the reading list I put together each year.
- [Non-dilutive Funding in a Nutshell](https://krogersconsulting.com/leadership/non-dilutive-funding-in-a-nutshell/) - As a startup founder, you have at least seven sources of non-dilutive funding to consider.
- [What Is Non-Dilutive Funding? Part 2](https://krogersconsulting.com/leadership/what-is-non-dilutive-funding-part-2/) - We are discussing sources of non-dilutive funding this month. Simply put, non-dilutive funding is startup money that doesn’t dilute your ownership of the business. Part 1 covered bootstrapping, friends and family support, and grants. This part covers debt financing and alternate funding approaches. I hope you are enjoying this mini-series! Adioma founder Anna Vital created
- [What Is Non-Dilutive Funding? Part 1](https://krogersconsulting.com/business/what-is-non-dilutive-funding-part-1/) - A two-part series exploring various non-dilutive funding options for startups, specifically those that allow founders to retain full ownership.
- [Making a New Medicine Part 3: Safety, Efficacy, Production, and the New Drug Application (NDA)](https://krogersconsulting.com/product-development/making-a-new-medicine-part-3/) - The discovery and development of a new medicine is a complex and lengthy process. Often, founders search for new therapies without understanding these details.
- [The Funding Expansion](https://krogersconsulting.com/ecosystem-development/the-funding-expansion/) - Even though it's harder to get funding now, these reports show it's still possible if founders are smart and realistic about their approach.
- [Podcast: How Katrina Rogers is Slashing Costs & Time in Life Sciences Innovation](https://krogersconsulting.com/product-development/podcast-how-katrina-rogers-is-slashing-costs-time-in-life-sciences-innovation/) - In my recent appearance on Life Science Success, I shared my journey of over 25 years in life sciences and my passion for transforming drug development.
- [Katrina in the Bullpen](https://krogersconsulting.com/leadership/katrina-in-the-bullpen/) - Have you seen my posts about the Bullpen and wondered, “What is this group, and why is Katrina involved?” Let me tell you how I was introduced to this club.
- [Fall Into Learning](https://krogersconsulting.com/leadership/fall-into-learning/) - Many people I meet are asking about ways to develop themselves personally and professionally. Here are four learning approaches you should consider.
- [Why Does Your Business Need Identifier Numbers?](https://krogersconsulting.com/business/business-identifier-numbers/) - Do you find yourself mystified by the identifier numbers and codes you are asked for while doing business? Let’s review these numbers to learn how they help.
- [Starting Up? 3 Must-Know Tips for Life Science Founders](https://krogersconsulting.com/product-development/three-must-know-tips-for-life-science-founders/) - Starting up in the life sciences? Here are three must-know tips for life science founders to know before launch!
- [Medical Device User Fees will increase in FY2019](https://krogersconsulting.com/uncategorized/medical-device-user-fees-will-increase-in-fy2019/) - The FDA’s CDRH branch posted the 2019 rates and payment procedures for Medical Device User Fees on July 30, 2018. See the table below for a comparison of the 2018 and 2019 fees. Most of these fees are set using a formula that references the standard fee for a premarket application, which will increase to
- [Is OMWBE Certification Necessary for Your Business? A Comprehensive Guide](https://krogersconsulting.com/business/is-omwbe-certification-necessary-for-your-business-a-comprehensive-guide/) - OMWBE (Office of Minority and Women Business Enterprises) certification can open doors to government contracts, but it's not for everyone.
- [Is Your Startup a Good Fit for SBIR/STTR Funding?](https://krogersconsulting.com/ecosystem-development/is-your-startup-a-good-fit-for-sbir-sttr-funding/) - Struggling to secure funding for your life science startup? Learn how SBIR/STTR grants can be a game-changer for innovative entrepreneurs.
- [Building the Next-Generation Life Science Workforce](https://krogersconsulting.com/talent-development/building-the-next-generation-life-science-workforce/) - Continued development and expansion of the life science industry in Washington State and the entire Intermountain Northwest depends on a diverse talent pool.
- [The eSTAR Program for 510(k) and De Novo Submissions](https://krogersconsulting.com/medical-products/the-estar-program-for-510k-and-de-novo-submissions/) - The FDA's electronic Submission Template and Resource (eSTAR) program currently supports medical device submissions for 510(k) clearance or De Novo evaluation.
- [Hidden Barriers: The Language of Business and Diversity](https://krogersconsulting.com/leadership/hidden-barriers-the-language-of-business-and-diversity/) - Business language is not just a tool for communication in business and entrepreneurship; it's a powerful force that shapes perceptions, decisions, and outcomes.
- [Measuring Female Founders - An Update](https://krogersconsulting.com/talent-development/measuring-female-founders-an-update/) - In the ever-evolving entrepreneurship landscape, female founders continue to make significant strides despite persistent challenges.
- [Female Founder Challenges in the EU](https://krogersconsulting.com/talent-development/female-founder-challenges-in-the-eu/) - I’m not the only one commenting on the challenges Femail Founders face. An article I wrote earlier this month also reviewed some facts about female founders.
- [One Entrepreneur’s Path – Your Results May Vary](https://krogersconsulting.com/leadership/one-entrepreneurs-path-your-results-may-vary/) - This is the personal entreperneur story of Katrina Rogers. The life science ecosystem is expanding in Spokane, Eastern Washington, and the Mountain Northwest.
- [Making a New Medicine Part 4: What Happens After Approval?](https://krogersconsulting.com/medical-products/making-a-new-medicine-part-4-what-happens-after-approval/) - The discovery and development of a new medicine are complex and lengthy processes. Many founders begin the search for a new drug without knowing the details.
- [Regulatory Guidance for Your Rare Disease Therapy](https://krogersconsulting.com/product-development/regulatory-guidance-for-your-rare-disease-therapy/) - Navigating the World of Rare Disease,: This month, let's dive into the complexities of developing therapies for rare diseases.
- [Talent Acquisition and Retention is Broken!](https://krogersconsulting.com/talent-development/talent-acquisition-and-retention-is-broken/) - The COVID-19 pandemic has highlighted many flaws in talent acquisition and retention strategies. Companies cannot find suitable candidates to fill positions, yet skilled individuals still need to get a callback after submitting their applications. It's taking weeks to hire, and managers struggle to keep their best talent. The primary issues include broken acquisition funnels, poor
- [NSF Research Funding to Build the American Bioeconomy – is it for you?](https://krogersconsulting.com/ecosystem-development/research-funding-to-build-the-american-bioeconomy/) - The NSF has stepped forward to lead the bioeconomy initiative with its new funding opportunity for research and education related to biotechnology.
- [The Upside and Downside of ML, AI, and Big Data](https://krogersconsulting.com/business/the-upside-and-downside-of-ml-ai-and-big-data/) - Artificial intelligence, machine learning, and big data have been big buzzwords in the tech and medical device field lately.
- [Seven Reflections for My Younger Self](https://krogersconsulting.com/leadership/seven-reflections-for-my-younger-self/) - Real-life stories from others give us a shared perspective that can trigger new ideas and launch us in different directions. It’s common for those new to a career to ask for advice, and many find the thoughts of an expert to their younger selves valuable. In this article, Katrina shares seven work- and life-improving insights,
- [FDA Guidance for Real World Data and Evidence](https://krogersconsulting.com/science/fda-guidance-for-real-world-data-and-evidence/) - The collection and use of Real World Data (RWD) and Real World Evidence (RWE) is a hot topic of conversation.
- [Resolving the Biomanufacturing Talent Shortage](https://krogersconsulting.com/talent-development/resolving-the-biomanufacturing-talent-shortage/) - The US government and many companies are investing in increasing biomanufacturing capacity in the Americas.
- [Customer and Product Discovery Through Data](https://krogersconsulting.com/medical-products/customer-and-product-discovery-through-data/) - [et_pb_section admin_label=”section”] [et_pb_row admin_label=”row”] [et_pb_column type=”4_4″][et_pb_text admin_label=”Text”] Over the past few years, I’ve been a mentor for startups launching from Washington State University (Go, Cougs!). Most of the co-founders I work with struggle to understand their product-market fit. They aren’t alone – customer discovery is a continuing challenge even for experienced founders. It’s easy to lose
- [The Operational Challenges Inherent to RWD/RWE](https://krogersconsulting.com/science/the-operational-challenges-inherent-to-rwd-rwe/) - What are the operational challenges of using RWD/RWE? In this article, I explain several of the challenges and provide references if you want to know more.
- [Turnaround Time and Success Rate for Medical Device Decisions](https://krogersconsulting.com/science/turnaround-time-and-success-rate-for-medical-device-decisions/) - All medical device companies need to include a success rate and time to decide on their submissions in their go-to-market plan.
- [What are the FDA’s Orange, Purple, and Green Books?](https://krogersconsulting.com/science/exploring-the-fdas-color-books/) - Among the many resources made available by the FDA, the Orange, Purple, and Green Books stand out for their names and content. These books address public demand for lower-cost drug products, which prompted laws and regulations requiring lists of alternatives.
- [Evergreen Bioscience Innivation Cluster Presentation to WSU ETM575 Class](https://krogersconsulting.com/science/evergreen-bioscience-innivation-cluster-presentation-to-wsu-etm575-class/) - I always love talking with students. A few weeks ago, I had the opportunity to share the Evergreen Bioscience Innovation Cluster with students in the Washington State University EM575 class.
- [Katrina’s 2022 Reading List](https://krogersconsulting.com/leadership/katrina-reading-list-2022/) - Once or twice a year, I like to look back through the list of books I have read and recommend a few to you. All of these are nonfiction, and several focus on personal development. I hope you enjoy them as much as I did. Reach out to me with your comments or suggestions for
- [Developing Your Strategic Planning Skills](https://krogersconsulting.com/leadership/developing-your-strategic-planning-skills/) - Strategic planning helps you identify the resources and steps necessary to reach the desired outcome and make the most of available resources.
- [University of Washington Biomedical Regulatory Affairs Masters Degree](https://krogersconsulting.com/science/university-of-washington-biomedical-regulatory-affairs-masters-degree/) - Here’s my CMC lecture for the 2023 University of Washington Biomedical Regulatory Affairs Masters Degree graduating class. In it, she explains how companies that produce drugs, biologics, and medical devices develop, validate, and operate processes that ensure the safety, efficacy, and quality of their products.
- [Making a New Medicine Part 2: Introducing Clinical Trials](https://krogersconsulting.com/medical-products/making-a-new-medicine-part-2-introducing-clinical-trials/) - The discovery and development of a new medicine is a complex and lengthy process. Many founders begin their search for a new therapy without these details.
- [What is Pharmaceutical Advanced Manufacturing?](https://krogersconsulting.com/science/what-is-pharmaceutical-advanced-manufacturing/) - Pharmaceutical manufacturing has traditionally been a batch-based process, with different stages of production being conducted in discrete steps.
- [How Does Cross-Curriculum Learning Support Bioscience Talent Development?](https://krogersconsulting.com/talent-development/how-does-cross-curriculum-learning-support-bioscience-talent-development/) - Over the past year, talent shortages across many industries were a frequent news story, and we expect the shortfall to increase over time.
- [The FDA's Approach to DHT is Evolving](https://krogersconsulting.com/science/digital-health-technologies/) - The FDA’s thinking on Digital Health Technologies (DHT) continues to evolve. They released the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development in March. This publication, a PDUFA VII commitment, will “guide activities such as (1) defining objectives for workshops and demonstration projects, (2) developing methodologies for evaluating DHTs
- [Making a New Medicine Part 1: Discovery and Development](https://krogersconsulting.com/medical-products/making-a-new-medicine-part-1-discovery-and-development/) - Discovering a new medicine is a complex journey that starts with identifying mechanisms for the target disease state and finding active drugs.
- [What are Some Possible Outcomes of the FDA Modernization Act of 2022?](https://krogersconsulting.com/ecosystem-development/fda-modernization-act/) - The Impact of the FDA Modernization Act 2.0 Late in December 2022, President Biden signed H.R. 2617 (117th): Consolidated Appropriations Act into law. While boringly titled, this Act contained the FDA Modernization Act 2.0, proposed initially as S.5002. While this change is not as sweeping as the Food and Drug Administration Modernization Act of 1997,
- [Building the Future Bioeconomy](https://krogersconsulting.com/ecosystem-development/building-the-future-bioeconomy/) - Defining and measuring the bioeconomy is challenging, and the need for more data and consensus on definitions makes it difficult to establish reasonable goals.
- [Uncommon Thoughts On SBIR/STTR Grants for Startup Success](https://krogersconsulting.com/leadership/uncommon-thoughts-on-sbir-sttr-grants-for-startup-success/) - SBIR/STTR grants are valuable resources for startup founders and researchers looking to fund their research and development efforts and turn their innovative ideas into successful startups. The SBIR/STTR program, which stands for Small Business Innovation Research and Small Business Technology Transfer, explicitly supports original projects with the potential to create significant commercial impact. By providing
- [The CDERDirect NextGen Collaboration Portal](https://krogersconsulting.com/medical-products/cderdirect-nextgen-collaboration-portal/) - Rapid and secure communication with the FDA is an essential task within the regulated industry, and CDER makes some communications easier through the NextGen Collaboration portal. This tool is part of the FDA's efforts to streamline and modernize the drug development process and to promote more efficient and effective drug development. The system allows applicants,
- [Tools for Transforming Drug Development](https://krogersconsulting.com/medical-products/drug-development/) - The FDA issued final guidance on the qualification process for Drug Development Tools (DDTS) in November 2020 after one round of revision and comments.
- [Hiring for Your Company’s Future](https://krogersconsulting.com/talent-development/hiring-for-your-companys-future/) - As a business owner or manager, hiring the right people is crucial for the growth and success of your company.
- [Female Founders: What’s Wrong With This Picture?](https://krogersconsulting.com/leadership/female-founders-whats-wrong-with-this-picture/) - The Harvard Business Review published an article with the triggering title “For Female Founders, Fundraising Only From Female VCs Comes at a Cost.”
- [Board Service Good Habits](https://krogersconsulting.com/leadership/board-service-good-habits/) - Serving on a board requires time, effort, and dedication. Are you ready to develop good habits to become a successful board member?
- [Strategic Planning for Medical Products](https://krogersconsulting.com/product-development/strategic-planning-for-medical-products/) - Part 1 - US Pharmaceutical Regulatory PathPharmaceuticals and medical devices are regulated in the USA by the FDA. The regulations started to diverge in 1976 following the passage of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. Each type of medical product has a different regulatory pathway with a sequence of stages,
- [Is This the Right Problem?](https://krogersconsulting.com/leadership/is-this-the-right-problem/) - Founders often fixate on a single problem, but using structured methods can enhance innovation and project success. This framework is applicable to startups.
- [Being Strategic About Lab Investments](https://krogersconsulting.com/leadership/being-strategic-about-lab-investments/) - LinkedIn recently asked me to answer the question, “How can you use cost-benefit analysis (CBA) to make informed lab investments?” Their AI explained the basic steps for performing a CBA. However, there was zero context for strategically thinking about a lab investment. I want to explore the strategic reasons why you should invest in a
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-2/) - Chapter 12 - Quarantine Reading List - Leadership It's clear we will need innovation and leadership to overcome the health and economic challenges posed by the pandemic to our businesses and community. While you are staying home to stay healthy, make a change to your schedule to incorporate some constructive reading. See my previous reading suggestions and
- [Device Submissions Are Now All Electronic](https://krogersconsulting.com/product-development/device-submissions-are-now-all-electronic/) - In December, the FDA issued a final rule revising all the regulations for medical device regulatory submissions to replace paper with electronic copies.
- [New Medicine Development](https://krogersconsulting.com/product-development/new-medicine-development/) - Part 1 - DiscoveryMay is our month to review how new medicines are developed. This will be an eight part series describing the different stages of drug development which are applicable in all regulatory jurisdictions.The aim of discovery research is to clearly identify the hypothetical mechanisms for the target disease state, develop relevant mechanistic models
- [Medical Device Development](https://krogersconsulting.com/product-development/medical-device-development/) - Part 1 – Medical Device DesignJune is our month to examine how new medical devices are approved. In this 4-part series we’ll focus on FDA regulatory pathways, although much of what we discuss can be applied in other jurisdictions. Global harmonization of device regulations is at a relatively early stage; however, frequent review of work
- [U.S. Strategy for Innovation - “Out Innovate With Everyone”](https://krogersconsulting.com/ecosystem-development/us-strategy-for-innovation-out-innovate-with-everyone/) - The National Advisory Council on Innovation and Entrepreneurship recently issued 10 strategic recommendations for strengthening entrepreneurship and innovation.
- [Making a Generic Drug](https://krogersconsulting.com/product-development/making-a-generic-drug/) - Making a generic drug might seem easy. This article will examine the process of making a generic drug, including its challenges and solutions.
- [Outbreak – Four Years Later](https://krogersconsulting.com/science/outbreak-four-years-later/) - March 2024 marks four years since the coronavirus outbreak and the global pandemic lockdown started. I wrote several articles spanning February – April 2020, sharing information and making some projections. This is a good time to reflect on the past and what we’ve learned and look forward to the future. Here are links to all
- [Focus on Women’s Health at the FDA](https://krogersconsulting.com/medicine/focus-on-womens-health-at-the-fda/) - In 2020, the FDA seemingly increased attention paid to women's health issues. It may shock you to learn that most medical research has been conducted on males.
- [The Importance of Rare Disease Research](https://krogersconsulting.com/product-development/the-importance-of-rare-disease-research/) - Learn how research into rare disease can help shape the future of healthcare.
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-12/) - It’s important to keep in mind that the risk of COVID-19 for most people outside of China is low.
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-11/) - Chapter 2 - Emergency Use Authorization of a Diagnostic Test for COVID-19 Many of us want to understand what our governments are doing in response to the public health emergency presented by COVID-19. As part of the US response, on February 4th the FDA authorized the emergency use of a diagnostic test developed by the Centers
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19/) - A coronavirus is a virus that typically causes respiratory symptoms in affected persons. It’s name comes from the tiny projections extending from the membrane that contains the viral DNA, which have the appearance of a crown, or corona in Greek (see the photo above, courtesy of the CDC). COVID-19, the virus causing the latest outbreak,
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-7/) - Chapter 7a – What to Do When There are Not Enough Lab Tests/Test Sites It’s pretty amazing how circumstances have changed in the past couple of weeks, and I’m sure the readers of this blog are adapting to the necessary changes to protect our communities. You may have heard the news stories about the impact
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-9/) - Chapter 7b - R&D for COVID-19 - Treatments and Vaccines Are in Development At the time of this post, there are no approved treatments for COVID-19. Severe cases are being treated with currently available respiratory standard of care, and companies with antiviral medications are working to make them more available in high impact areas. Companies
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-13/) - You may feel stressed and anxious about the COVID-19 outbreak.
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-10/) - Chapter 3 - Controlling the Spread of COVID-19 - Global Response Reports of a new and severe respiratory infection first started emerging from China in early December 2019. On February 11, 2020, WHO gave the new coronavirus its official name of COVID-19. Public health agencies around the globe are actively working to control the spread
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-15/) - Chapter 14 - FDA’s Coronavirus Treatment Acceleration Program (CTAP) Recognizing the need for rapid COVID-19 pandemic response, the FDA has created the Coronavirus Treatment Acceleration Program (CTAP) to move new treatments to patients as quickly as possible while still maintaining scientifically based standards for evaluating treatment safety and effectiveness. The purpose of the program is
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-8/) - Chapter 6 – Biomedical Mobilization Against COVID-19 The response of our biomedical community to the novel coronavirus outbreak has been impressive, and is illustrated in this slide from a JP Morgan webcast on COVID-19 and the Markets held on March 20th (see here for more information on the subject from some very smart people at JP Morgan).
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-6/) - Chapter 8 - More Immediate Actions by the FDA to Increase Medical Supplies The COVID-19 outbreak has created shortages of medical supplies such as gloves, masks, hand sanitizer, and respiratory ventilators (the last essential for treatment of critical care patients). The restrictions on plants that sterilize medical products with ethylene oxide (see my previous posts
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-5/) - Chapter 9 – Preparing for an Epidemic Here’s a Ted Talk from 2015 by Bill Gates which presents a strikingly (though not surprisingly) prescient look at the ‘next epidemic’. What I like best about this talk are the preparedness ideas he presents. I’ve already shown you how the pharmaceutical industry has been responding to the crisis, and
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-4/) - Chapter 10 – Are Your Clinical Trials Impacted by COVID-19? Because I spend a lot of time thinking about the approval process for new medical products, I had already begun to consider the impact of travel and access restrictions on the conduct of clinical trials. Trial disruptions may include difficulties in following the protocol to
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-3/) - Chapter 11 – CDER Creates a Single Site for Its COVID-19 Response Activities So much new information is being released daily by the FDA in response to the COVID-19 outbreak that it can be hard to keep track of the latest developments or current guidance. Some immediately in effect guidance have been updated a couple
- [Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)](https://krogersconsulting.com/covid/outbreak-combating-the-2019-novel-coronavirus-covid-19-14/) - Chapter 13 - NIH Foundation is Coordinating a Global Research Effort This month, NIH launched a public-private partnership to develop an international strategy for the research on the COVID-19 pandemic. Part of the “part of the whole-of-government, whole-of-America response” to the pandemic, the partnership includes NIH, FDA, CDC, the European Medicines Agency (EMA), and 16
- [Setting Drug Expiration Dates](https://krogersconsulting.com/medical-products/setting-drug-expiration-dates/) - Have you ever wondered how the expiration date is determined for a pharmaceutical product you’ve used? Whether prescription or over the counter, all medications have their expiration dates determined through a stability program in which batches of the product are held at the recommended long-term storage conditions and tested at regular intervals. The expiration date
- [Do Value Based Agreements Ensure Patient Access To New Medicines?](https://krogersconsulting.com/medical-products/do-value-based-agreements-ensure-patient-access-to-new-medicines/) - Alnylam Pharmaceuticals recently announced a new Value Based Agreement (VBA) framework for their newly approved RNAi medicine to treat acute hepatic porphyria, a group of rare genetic diseases due to one or more deficiencies in the heme biosynthesis pathway in the liver. The framework is supposed to make it easier for payers to sign agreements
- [For Rare Disease Day 2020 - An Article](https://krogersconsulting.com/medicine/for-rare-disease-day-2020-an-article/) - As we approach Rare Disease Day this year (February 29th), I’d like to share this PharmaVOICE article on the impact of rare diseases and the efforts underway to address these challenges. As the article notes, while these diseases may be rare because they individually affect a small population, cumulatively they affect more people than cancer
- [Standards Organizations Play a Role in Medical Product Regulation](https://krogersconsulting.com/medical-products/standards-organizations-play-a-role-in-medical-product-regulation/) - Standards organizations create necessary standard for global access to safe and effective treatments.
- [Do Value-Based Agreements for New Medicines Work?](https://krogersconsulting.com/product-development/do-value-based-agreements-for-new-medicines-work/) - The definition and structure of value-based agreements, their potential, the evidence they are effective, and what policy changes would help adoption.
- [Katrina’s Reading List – Making the Cut](https://krogersconsulting.com/leadership/katrinas-reading-list-making-the-cut/) - Katrina’s Reading List – Making the Cut. For those not yet aware of the fact, reading is my superpower.
- [What are the Pharmacopoeia?](https://krogersconsulting.com/medical-products/what-are-the-pharmacopoeia/) - Pharmacopoeia was a book of medicinal drugs. The pharmacopoeia are regional organizations devoted to creating and maintaining standards to ensure public health.
- [Katrina’s Reading List from 2023](https://krogersconsulting.com/leadership/katrinas-reading-list-from-2023/) - Every year, I assemble a reading list of notable books I’ve read and want to share with you.
- [Preparing for Strategic Investor and Partner Meetings](https://krogersconsulting.com/product-development/preparing-for-strategic-investor-and-partner-meetings/) - The first step for small companies with limited resources is understanding your priorities, purpose, and desired outcomes for investor meetings.
- [Using Inspection Procedures & Guides as a Preparation Tool for Medical Device Inspection](https://krogersconsulting.com/product-development/using-inspection-procedures-guides-as-a-preparation-tool/) - Developing a medical product? Sooner or later, you will face a regulatory inspection.
- [What are Skills-Based Talent Practices, and Why Should I Care?](https://krogersconsulting.com/talent-development/what-are-skills-based-talent-practices-and-why-should-i-care/) - There are three reasons why your company should use skills-based talent practices: find the right people, increase retention, and expand the talent pool.
- [Three-Tiered Approach to Regulation of Next Generation Sequencing](https://krogersconsulting.com/product-development/three-tiered-approach-to-regulation-of-next-generation-sequencing/) - With the approval of three new next-generation sequencing diagnostic tests for tumor profiling, CDRH also announced its approach to regulating such tests.
- [Thinking About Hiring a New CEO?](https://krogersconsulting.com/talent-development/thinking-about-hiring-a-new-ceo/) - Hiring a new CEO for your startup is not impossible, but it should be done conscientiously to maintain company culture and values.
- [2020 Good for Pharmaceuticals and Life Sciences Deals?](https://krogersconsulting.com/medical-products/2020-good-for-pharmaceuticals-and-life-sciences-deals/) - There’s a lot of investment capital floating around out there, and the Pharmaceuticals and Life Sciences (PLS) sector could benefit this year. According to a report by international accounting firm PwC, there’s considerable money and investment interest in the space, including over $1.7T in private equity. And this week’s BIO CEO & Investor Conference in
- [Use Quality Principles to Blast Past Compliance Into Excellence](https://krogersconsulting.com/product-development/use-quality-principles-to-blast-past-compliance-into-excellence/) - The FDA has long supported a quality approach to improve the safety of medical products. The Case for Quality captures the continuing efforts to encourage medical device manufacturers to apply quality principles to their products and operations. The program was started in 2011 after a review showed an investment in quality would have long-term payoffs
- [The Challenge of Innovation Leadership](https://krogersconsulting.com/leadership/the-challenge-of-innovation-leadership/) - Increasing complexity is one reason why innovation leadership is challenging. An innovation cluster facilitates transformative change in eight ways.
- [The Increased Role of International Harmonization Efforts in FDA](https://krogersconsulting.com/product-development/the-increased-role-of-international-harmonization-efforts-in-fda/) - It appears to me that the FDA is increasing its use of medical products harmonization document as a source for regulatory guidance in recent years. For example, during the Pharmaceutical Quality Symposium in October, Tara Groen and Rapti Maudurawe of the FDA noted the agency will not pursue the draft guidance on continuous manufacturing but
- [The Compliance Program Guidance Manual Guides Inspections](https://krogersconsulting.com/uncategorized/the-compliance-program-guidance-manual-guides-inspections/) - Similar to the MAPP discussed in a previous post, the Compliance Program Guidance Manual (CPGM) contains the instructions used by FDA personnel to perform the agency’s compliance work. Unlike the MAPP, the instructions in the CPGM are more like FDA guidance in that they create no rights or obligations and another approach may be used
- [Streamlined Process for Investigational In Vitro Devices](https://krogersconsulting.com/medical-products/streamlined-process-for-investigational-in-vitro-devices/) - Codeveloped with Oncology Drugs The FDA released a procedural guidance in October 2019 which provides a streamlined process for submitting investigational in vitro devices (IVD) being codeveloped with investigational drugs in the same clinical protocol. The process requires one of the sponsors to take the lead role on the device with the agency and
- [Cybersecurity for Medical Devices Part 2](https://krogersconsulting.com/medical-products/cybersecurity-for-medical-devices-part-2/) - Conduct Your Risk Assessment Using the CVSS Standard Management of cybersecurity across the lifecycle of a medical device includes repeat assessments of the device’s vulnerabilities, categorization of their severity, and prioritizing risk mitigation and controls. The FDA encourages the use of accepted standards in the evaluation of medical devices and has selected the Common Vulnerability
- [Understanding CDER Through Its Policies and Procedures](https://krogersconsulting.com/medicine/understanding-cder-through-its-policies-and-procedures/) - An organization with a robust quality system will have established policies and procedures, so it should be no surprise that CDER has a full set. By law, these must be available to the public, so they have been published on the CDER website as the CDER Manual of Policies and Procedures (MAPP). A review of
- [What is a Drug Master File (DMF)?](https://krogersconsulting.com/medical-products/what-is-a-drug-master-file-dmf/) - A Drug Master File, or DMF, is a submission to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. There are four types of DMFs: Type II - for drug substance, drug substance intermediate, and materials used in their
- [The 21st Century Cures Act Changed What is Considered a Device](https://krogersconsulting.com/uncategorized/the-21st-century-cures-act-changed-what-is-considered-a-device/) - Check out new guidance and webinar for details As I’ve previously mentioned, section 3060 of the 21st Century Cures Act specifically exempts certain types of software functions from FDA regulatory oversight as medical devices. CDRH has issued the final level 1 guidance on these software functions and made level 2 updates to guidance on the
- [Cybersecurity for Medical Devices Part 1](https://krogersconsulting.com/uncategorized/cybersecurity-for-medical-devices-part-1/) - IMDRF Draft Guidance is Available for Comment until December 2, 2019 The International Medical Device Regulators Forum released a draft guidance on cybersecurity in early October, and it will be available for public comment until December 2nd. The guidance reinforces the role of the total product lifecycle approach in the management and mitigation of cybersecurity
- [New Modules posted on CDRH Learn](https://krogersconsulting.com/medical-products/new-modules-posted-on-cdrh-learn/) - CDRH posted seven new modules on the CDRH Learn web page at the end of September/beginning of October. These new modules are: Under The Basics How is CDRH Structured? Is My Product a Medical Device? Under How to Study and Market Your Device Introduction to the Premarket Approval Application (PMA) Program Premarket Approval Application (PMA)
- [The Drug Development Tool Qualification Programs](https://krogersconsulting.com/uncategorized/the-drug-development-tool-qualification-programs/) - The FDA has established 3 programs for qualification of Drug Development Tools (DDT): Animal Models, Clinical Outcome Assessments, and Biomarkers A qualified DDT is publicly available to be used in any drug development program for its qualified context of use, and when used as qualified will not require FDA reconsideration of suitability. Since the qualification
- [Guidance on Clinical Bioanalysis](https://krogersconsulting.com/uncategorized/guidance-on-clinical-bioanalysis/) - Q&A on Evaluating Internal Standard Response In September, the CDER issued a level 2 guidance containing a series of questions and answers on the evaluation of internal standard responses during bioanalysis of clinical trial samples. Normally used in chromatographic tests to measure the trial drug, an internal standard (IS) is a structurally similar analog or
- [The FDA’s Clinical Outcomes Assessment Compendium](https://krogersconsulting.com/uncategorized/the-fdas-clinical-outcomes-assessment-compendium/) - Are you planning the clinical phase for your new therapy and wondering what measures of clinical outcomes have been used successfully for other drugs or biologics? One place to start your research could be the FDA’s Clinical Outcomes Assessments Compendium, which received an update in August. The compendium tables show how certain clinical outcomes assessments
- [Spokane’s Steve Gleason Institute for Neuroscience](https://krogersconsulting.com/uncategorized/spokanes-steve-gleason-institute-for-neuroscience/) - In early 2019, Washington State University Health Sciences Spokane announced the formation of the Steve Gleason Institute for Neurodegeneration. Dedicated to the development of effective treatment strategies for neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Parkinson’s, and other diseases. The Institute has the support of multiple community partners including Avista, the Health Sciences &
- [Electronic Regulatory Submissions Part 16](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-16/) - The Move to eCTD v4 (Note: This post is part of a multi-part series on the CTD this fall) The eCTD version current at the time of the post is v.3.2.2, with the complete specification contained in this 2008 document. This document has the clearest explanation I’ve found of the rationale for the system ‘s
- [Electronic Regulatory Submissions Part 15](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-15/) - The Application Lifecycle (Note: This post is part of a multi-part series on the CTD this fall) An NDA or BLA is not a static document; rather, it is a living collection of information that evolves through the lifecycle of the drug. In the earliest lifecycle phases (before a drug has been approved), the application
- [Electronic Regulatory Submissions Part 14](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-14/) - Formatting the eCTD (Note: This post is part of a multi-part series on the CTD this fall) It appears to me that the explanations on the eCTD program page are targeted towards those who build XML publishing tools rather than users. That’s one reason why the structure and process seems so complicated. Review of some
- [Electronic Regulatory Submissions Part 13](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-13/) - How the eCTD Works (Note: This post is part of a multi-part series on the CTD this fall) The eCTD is, at heart, an electronic structure to organize and present submission for ease of review. The specifications for the eCTD are in the FDA’s Technical Conformance Document and the eCTD Submission standards (find the latest
- [Electronic Regulatory Submissions Part 12](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-12/) - CTD Organization Makes Finding Information Simpler (Note: This post is part of a multi-part series on the CTD this fall) Part of what makes the CTD so useful is its internal structure. We can look at the Quality Overall Summary (QOS) as an example (see the M4Q guidance for reference). The guidance table of contents
- [Electronic Regulatory Submissions Part 11](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-11/) - What’s in Module 5 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 5 contains the clinical study reports about the new drug. The overview and summaries for these studies are included in module 2 sections 5 and 6. Module 5 contains all the detailed reports
- [Electronic Regulatory Submissions Part 10](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-10/) - What’s in Module 4 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 4 contains the nonclinical study reports about the new drug. The overview and summaries for these studies are included in module 2 sections 4and 6, respectively. Module 4 contains all the detailed reports
- [Electronic Regulatory Submissions Part 9](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-9/) - What’s in Module 3 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 3 of the CTD contains the Quality data, which is the detailed information on the chemistry, manufacturing process, and control strategy for both the drug substance (the active material, whether chemical or biologic)
- [Electronic Regulatory Submissions Part 8](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-8/) - What’s in Module 2 of the CTD? (Note: This post is part of a multi-part series on the CTD this fall) Module 2 of the CTD contains summaries of information presented in detail in modules 3-5. It starts with a one-page introduction that covers the pharmacologic class, mode of action, and proposed clinical use. The
- [Electronic Regulatory Submissions Part 7](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-7/) - Module 1: Regional Administrative Information and Prescribing Information Because the eCTD is based on the ICH CTD, my next few posts will cover the content in each of the specific CTD modules. Module 1 contains the region-specific information and is the only module that will vary based on where the application will be submitted. The
- [Electronic Regulatory Submissions Part 6](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-6/) - The History of the CTD and eCTD (Note: This post is part of a multi-part series on the CTD this fall) The history of the ICH eCTD is shown in this ICH slide deck from 2011, a program overview presented by the Rapporteur (that’s the person appointed to report the proceedings of a group’s meetings)
- [Electronic Regulatory Submissions Part 5](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-5/) - The Common Technical Document Provides a Structure for Submission (Note: This post is part of a multi-part series on the CTD this fall) Before it became electronic, the common technical document (or CTD) was proposed by an ICH steering committee as a means to efficiently combine the efficacy, quality, and safety data for a drug
- [Electronic Regulatory Submissions Part 4](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-4/) - Stay Current on Guidance When Planning Your Submissions (Note: This post is part of a multi-part series on the CTD this fall) In my last post in the series we reviewed what we could find on the history of a main eCTD guidance. There are a fair number of eCTD related guidance, and they change
- [Electronic Regulatory Submissions Part 3](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-3/) - What’s the Current eCTD Guidance? (Note: This post is part of a multi-part series on the CTD this fall) In my previous post, we reviewed the types of submissions for which the FDA requires eCTD format. One of the earliest guidance for eCTD still available was issued in January of 1999, and it starts with
- [Electronic Regulatory Submissions Part 2](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-2/) - What has to be submitted electronically? (Note: This post is part of a multi-part series on the CTD this fall) The eCTD guidance is one of the very few that specify requirements for applicants; most include a statement that the guidance represents the agency’s current thinking and are not binding on any party. Under eCTD
- [Electronic Regulatory Submissions Part 1](https://krogersconsulting.com/uncategorized/electronic-regulatory-submissions-part-1/) - What is the Electronic Common Technical Document? (Note: This post is part of a multi-part series on the CTD this fall) Since 2017/2018, CDER and CBER have required all applications, amendments, supplements, and reports be submitted electronically using the Electronic Common Technical Document or eCTD format. The eCTD is part of a broader set of
- [Recovering from a Warning Letter?](https://krogersconsulting.com/uncategorized/recovering-from-a-warning-letter/) - Difficult but not impossibleAt some point in your pharmaceutical/medical device career, you will likely be part of a company at the receiving end of an agency warning letter. How you respond will determine whether your company survives. Here are a few pointers from the trenches of a warning letter response:Embrace the suck – the situation
- [Inspection observations are inevitable](https://krogersconsulting.com/uncategorized/inspection-observations-are-inevitable/) - It’s how you handle them that matters!The time to prevent inspection observations is before the inspectors arrive! If you aren’t making effective use of your internal audit programs to identify and remediate problems and trends, you should start work to improve them immediately. Even if you are being diligent with your quality systems, you will
- [File now for User Fee Small Business Qualification](https://krogersconsulting.com/uncategorized/file-now-for-user-fee-small-business-qualification/) - for substantial savings on medical device application fees in FY2019As I mentioned in a previous post, there is a substantial reduction in the user fees for most types of medical device applications for small businesses. Certified small businesses are also eligible for a fee waiver on their first PMA (including modular PMA, BLA, PDP, or
- [How consensus data standards enable drug submissions at the FDA](https://krogersconsulting.com/uncategorized/how-consensus-data-standards-enable-drug-submissions-at-the-fda/) - Good data standards enable the effective sharing and comparison of scientific data. For example, the international drug regulatory agencies use a consensus standard called eCTD to help them receive, process, review, and archive submission data more effectively. Data submitted in a standard format may also be combined across many studies to explore new health and
- [The FDA is running out of 5 digit NDC codes](https://krogersconsulting.com/uncategorized/the-fda-is-running-out-of-5-digit-ndc-codes/) - The FDA has announced a public hearing on 4 approaches to gather comments on proposed changes to the current National Drug Code (NDC). The NDC is a 10- or 11-digit universal product identifier for human drugs in the United States, quickly identifying the labeler (manufacturer, packager) in the first segment, the product (strength, dosage form,
- [Birth Control for Millennial Women – Just Check your Phone](https://krogersconsulting.com/uncategorized/birth-control-for-millennial-women-just-check-your-phone/) - Last week’s FDA approval of Natural Cycles, a mobile medical app, makes available in the US a personal and discreet form of birth control that’s been available to EU women since August 2017. The app uses early morning temperature measurements logged by the user to determine her position in the menstrual cycle, allowing her to
- [The Future of RNAi Therapeutics is AntiAging](https://krogersconsulting.com/uncategorized/the-future-of-rnai-therapeutics-is-antiaging/) - The FDA approved Onpattro last week, the first approved medicine to use small interfering RNA (siRNA) to prevent formation of disease causing proteins in the body. This class of therapeutics, known more generally as RNAi, is expected to create breakthroughs in the treatment difficult diseases caused by the deposition of abnormal proteins such as hereditary
- [The time has come for consensus medical data standards!](https://krogersconsulting.com/uncategorized/the-time-has-come-for-consensus-medical-data-standards/) - Standards for the collection, storage, and sharing of data have been important at least since the invention of the printing press in 1440. Just think of how a typical book is organized, with a title page, table of contents, chapters and sections, and perhaps an index. Governments developed data standards for radio and television in
- [Why Labeling and Packaging is one of the 6 Critical GMP Systems](https://krogersconsulting.com/uncategorized/why-labeling-and-packaging-is-one-of-the-6-critical-gmp-systems/) - Announcement this week of the recall of a batch of blood pressure medication from Accord Healthcare Inc (read the recall notice here) reminds us why Labeling and Packaging is one of the 6 critical GMP systems. The drug product (hydrochlorothiazide HCl, a commonly used medicine for lowering blood pressure) appears from the initial investigation to
- [CDRH Seeks Advice from Experts and Consumers](https://krogersconsulting.com/uncategorized/cdrh-seeks-advice-from-experts-and-consumers/) - On August 23rd, the FDA posted a request for nomination of individuals willing to serve on the public advisory committees for Device Good Manufacturing Practice and Medical Device subtypes. The agency seeks the help of technically qualified scientific and clinical experts to review data on the safety and effectiveness of marketed and investigational medicines and
- [Opportunity to Train CDRH Reviewers is Now Open](https://krogersconsulting.com/uncategorized/opportunity-to-train-cdrh-reviewers-is-now-open/) - The Center for Devices and Radiological Health (CDRH) is now accepting applications from medical device companies, academia, and healthcare companies to host a site visit for CDRH reviewers (both new and experienced) to help them better understand patient needs and current industry practices with respect to the development and use of medical devices. The current
- [Are you ready for eCTD 4.0?](https://krogersconsulting.com/uncategorized/are-you-ready-for-ectd-4-0/) - Companies who are using eCTD for submissions or developing eCTD tools should take note that the ICH M8 group completed an update to the ICH eCTD v4.0 Implementation Package during the ICH June 2018 meeting. The updated implementation package (v1.3) should be posted on the ICH eCTD v4.0 webpage in August 2018. Concurrently within the CBER-CDER
- [What Types of Software are Regulated as a Medical Device?](https://krogersconsulting.com/uncategorized/what-types-of-software-are-regulated-as-a-medical-device/) - The 21st Century Cures Act of 2016 deregulated certain medical software, including: Software that supports administrative functions like billing or reimbursement Software that encourages a healthy lifestyle, Software that serves as electronic patient records, Software that assists in displaying or storing data, and Software that provides limited clinical decision supportAccording to CDER, these types of software will no longer be
- [CDER Drug Review Process Modernization Plans](https://krogersconsulting.com/uncategorized/cder-drug-review-process-modernization-plans/) - In a blog post last June, CDER director Janet Woodcock announced her proposed changes to the Center’s regulatory and review process for new drugs. These changes include:Enhancing recruitment and career development of a diverse group of scientistsEstablishing, integrating, and improving the coordination of multidisciplinary review teamsEnhancing IT capabilities and information organization to make it easy
- [What Federal Laws Apply to My Mobile Health App?](https://krogersconsulting.com/uncategorized/what-federal-laws-apply-to-my-mobile-health-app/) - Health-related mobile apps, particularly those that collect, create, or share consumer information, are regulated under a variety of federal laws, including the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (HIPAA), the Federal Food, Drug and Cosmetics Act (FD&C Act), and the FTC’s Health Breach Notification Rule. This
- [Digital Health will be the Next Big Thing](https://krogersconsulting.com/uncategorized/digital-health-will-be-the-next-big-thing/) - The announcement this week that Jack Stoddard will be the COO of the yet to be cleverly named new health venture created by Amazon, Berkshire Hathaway and J.P. Morgan should clarify for my readers that digital health will be the next big thing. In addition to being driven by business leaders familiar with disruptive change,
- [First Anniversary of the Digital Health Innovation Action Plan](https://krogersconsulting.com/uncategorized/first-anniversary-of-the-digital-health-innovation-action-plan/) - What is it, and what has been done? In late July the FDA celebrated the one-year anniversary of the Digital Health Innovation Action Plan. This initiative (run by the Center for Devices and Radiological Health) is focused on improving and streamlining the agency’s approach to digital health products in categories such as mobile health, health
- [Antibiotic-Resistance is a Serious Public Health Challenge](https://krogersconsulting.com/uncategorized/antibiotic-resistance-is-a-serious-public-health-challenge/) - I was surprised this month to find Methicillin-Resistant Staphylococcus Aureus (better known as MRSA) on a clinical admissions form for patients to list existing conditions prior to treatment. It was right there alongside more commonly observed conditions like high blood pressure and diabetes. After making this observation, I went to the CDC website on Antibiotic/Antimicrobial
- [Measuring your New Drug](https://krogersconsulting.com/uncategorized/measuring-your-new-drug/) - In order to provide the necessary data for an IND, you’ll need to apply some analytical chemistry to create methods for measuring your drug. For efficacy and exposure, you’ll need methods to measure the presence and concentration over time in in vitro samples (such as buffers, cell suspensions, and other simple or complex test solutions)
- [You Can Report Problems with Medical Products to the FDA](https://krogersconsulting.com/uncategorized/you-can-report-problems-with-medical-products-to-the-fda/) - This month the FDA posted a notice on updates to the forms for reporting adverse events related to medical products (either drugs or devices) to the agency. Manufacturers and compounders have a regulatory mandate to report serious adverse events and they use form 3500A for that purpose. Form 3500 is for voluntary reports by healthcare
- [Advisory Committees are One Way the FDA Gathers Public Feedback](https://krogersconsulting.com/uncategorized/advisory-committees-are-one-way-the-fda-gathers-public-feedback/) - Readers may not be aware that the FDA has a number of approaches to gather feedback on regulations, programs, and other proposed changes to how the agency operates. One of the ways the agency obtains independent expert advice on scientific, technical, and policy issues is through 50 Advisory Committees. Each committee supports a specific division
- [Electronic Submission Gateway](https://krogersconsulting.com/uncategorized/electronic-submission-gateway/) - What It Is and Why We Need It The FDA’s Electronic Submissions Gateway (ESG) is a tool that facilitates the secure transmission of electronic submissions from industry partners to the agency. The Gateway is not part of the actual review process; instead, it provides a means for receiving and acknowledging a submission, routing the submission
- [Medical Device Submissions Will Soon Be Entirely Electronic](https://krogersconsulting.com/uncategorized/medical-device-submissions-will-soon-be-entirely-electronic/) - This month the FDA proposed a new rule to remove the requirements for medical device premarket submissions to be made on paper with multiple copies and replace them with a requirement for a single submission in electronic format (known as an eCopy). As a bit of background, before the technological and cultural shifts brought about
- [CDER Procedure Update](https://krogersconsulting.com/uncategorized/cder-procedure-update/) - Establishing Limits for Impurities in DrugsCDER issued an update to MAPP 5017.2 R1 [revised 01MAY2020, updated link as of 09DEC2020] in September to clarify the review instructions for drug substance and drug product impurity acceptance criteria. The change clarified instructions for products with monographs with impurity acceptance criteria greater than the limits proposed in ICH
- [FDA’s eSubmitter Software – A Tool to Help Prepare Submissions](https://krogersconsulting.com/uncategorized/fdas-esubmitter-software-a-tool-to-help-prepare-submissions/) - The FDA offers a free software package called eSubmitter designed to help companies prepare electronic documents for selected regulated submissions (for example, CBER Annual Reports or CDRH eMDR reporting under form 3500A). The tool creates a package of documents on your local computer that may be uploaded to the appropriate Center’s office using a secure
- [Collaborative Communities Initiative for Medical Devices](https://krogersconsulting.com/uncategorized/collaborative-communities-initiative-for-medical-devices/) - One of the current strategic priorities for CDRH is the creation of Collaborative Communities to allow interested stakeholders (both private and public, including the FDA) to work together medical device challenges. These communities may be convened by any stakeholder, and “may exist indefinitely, produce deliverables as needed, and tackle challenges with broad impacts”. To further this
- [CTD standards for ANDAs – New Guidance](https://krogersconsulting.com/uncategorized/ctd-standards-for-andas-new-guidance/) - Generic drugs offer a significant cost savings to patients and payors, and one reason they cost less is the path to FDA approval is shorter. Any proposed drug product that can be shown to be the same as a Reference Listed Drug (RLD) “with respect to active ingredient(s), dosage form, route of administration, strength, previously
- [The ECG app for the Apple Watch](https://krogersconsulting.com/uncategorized/the-ecg-app-for-the-apple-watch/) - Represents a Shift in Thinking at the FDA The ECG app announced by Apple for the Series 4 Apple Watch has the potential to change how we think about and use our personal devices to improve our health and engage our healthcare providers. It also represents an important shift in thinking for the FDA on
- [Patient Focused Drug Development Guidance Workshop in October](https://krogersconsulting.com/uncategorized/patient-focused-drug-development-guidance-workshop-in-october/) - The FDA announced a two-day public workshop to discuss Patient Focused Drug Development on October 15-16th at their White Oak Campus in Maryland. The meeting is being held to gather public feedback to create patient-focused drug development guidance as required by the 21stCentury Cures Act of 2016. The meeting will focus on these topics to
- [Regulations, Procedures, and Guidance](https://krogersconsulting.com/uncategorized/regulations-procedures-and-guidance/) - Keeping Track of FDA Requirements for Medical ProductsThe FDA is a complex organization with a wide range of responsibilities in human and animal health and safety. Even when you know which office or center is responsible for a topic, the range of instructions available on that topic can be confusing. Which set of documents contain
- [What is the Division of Applied Regulatory Science?](https://krogersconsulting.com/uncategorized/what-is-the-division-of-applied-regulatory-science/) - and what do they do?Part of the Office of Clinical Pharmacology, the Division of Applied Regulatory Science (DARS) performs applied research to “develop and evaluate novel tools, standards, and approaches to assess the safety, efficacy, quality, and performance of CDER regulated products”. Division staff also consult with CDER reviewers on safety evaluations of new products,
- [Question-based Review Process Improves ANDA Submission and Review](https://krogersconsulting.com/uncategorized/question-based-review-process-improves-anda-submission-and-review/) - Following the release of the report “Final Report on Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach” in 2003, the Office of Generic Drugs (OGD) recognized that its process for review of ANDAs needed an update to meet the new risk-based approach and to handle a significant increase in submitted ANDAs since 2002
- [Webinar on Quality Systems Basics for Device Manufacture](https://krogersconsulting.com/uncategorized/webinar-on-quality-systems-basics-for-device-manufacture/) - The Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) will be hosting a workshop for medical device manufacturers on November 6, 2018. The workshop, which has a webinar format, will focus on 2 parts of the Quality Systems Regulation (21 CFR Part 820): Production and Process Controls
- [What is the Quality in 501(k) (“QUIK”) Review Program Pilot?](https://krogersconsulting.com/uncategorized/what-is-the-quality-in-501k-quik-review-program-pilot/) - CDRH is currently running a pilot program to accept 510(k) premarket notification submissions packaged using the eSubmitter tool (see my previous post). The purpose of the pilot is to collect information to assess the value of the template in facilitating review and approval of eligible submissions. The main differences between the pilot and the regular
- [Draft Guidance on Managing Cybersecurity in Medical Devices](https://krogersconsulting.com/uncategorized/draft-guidance-on-managing-cybersecurity-in-medical-devices/) - Now Open for CommentThis month the FDA released a draft guidance on managing cybersecurity in Medical Devices (“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”; download the draft here). The guidance will available for public comment under Docket FDA-2018-D-3443 starting on October 18, 2018 until March 18, 2019. When finalized, this draft
- [The Bose Hearing Aid permits user adjustment in real time](https://krogersconsulting.com/uncategorized/the-bose-hearing-aid-permits-user-adjustment-in-real-time/) - The FDA granted a De Novo classification for the Bose Hearing Aid on October 5, 2018. The De Novo program allows manufacturers to submit a request for a device to receive a new classification under categories I or II when a new medical device can be shown to have reasonable safety and efficacy for the
- [Learn about Medical Device Regulations at the CDRH Learn Web Page](https://krogersconsulting.com/uncategorized/learn-about-medical-device-regulations-at-the-cdrh-learn-web-page/) - Readers of this blog will be familiar with the webinars and workshops sponsored by CDRH as learning opportunities on the regulatory science for medical devices. If you are looking for continuing education on the subject, try the CDRH Learn page. A few new modules were released in October that may be of interest to our
- [What is Expanded Access?](https://krogersconsulting.com/uncategorized/what-is-expanded-access/) - Expanded Access (EA) is a program run by the Reagan-Udall Foundation to provide some patients with serious, life-threatening illnesses access to investigational treatments not yet approved by the FDA. Also known as compassionate use, named-patient use, or single-patient access, information about program is available on the Foundation’s web site through the EA Navigator page. Patients
- [WSU Translational Medicine Symposium](https://krogersconsulting.com/uncategorized/wsu-translational-medicine-symposium/) - Last week I participated in the 2018 Translational Medicine Symposium held on the campus of Washington State University in Spokane, WA. This annual conference is planned to discuss novel solutions for clinical problems, and this session covered clinical trials in 2 panels, research on the early detection of autism spectrum disorder, as well as manufacturing
- [SBIA offers a great way for small businesses to get help from FDA](https://krogersconsulting.com/uncategorized/sbia-offers-a-great-way-for-small-businesses-to-get-help-from-fda/) - Small pharmaceutical companies are at a distinct disadvantage when it comes to understanding and accessing the process for new or generic drug approval. Many of these companies have one person fulfilling many roles, and their teams may have limited direct experience with one or more aspects of the approval process. The Small Business and Industry
- [Benefit-Risk Determinations in Pre-market Approvals for Devices](https://krogersconsulting.com/uncategorized/benefit-risk-determinations-in-pre-market-approvals-for-devices/) - – new draft and final guidanceOver the past decade, the FDA has published a number of guidance documents on benefit-risk determinations for a variety of medical device application types. This fall the agency supplemented that guidance package by releasing two additional guidance documents. The first is a draft guidance on how to consider uncertainty when
- [Use of Consensus Standards to Meet Submission Requirements](https://krogersconsulting.com/uncategorized/use-of-consensus-standards-to-meet-submission-requirements/) - The FDA hosted a webinar in October in conjunction with release of the final guidance discussing the appropriate use and documentation of consensus standards in submissions as well as how the agency intends to rely on them during review. Consensus standards (also known as voluntary consensus standards) are guidelines produced by national or international standards
- [What is De Novo Classification for Medical Devices?](https://krogersconsulting.com/uncategorized/what-is-de-novo-classification-for-medical-devices/) - In a previous post, I mentioned the Bose Hearing Aid was approved by CDRH under the De Novo Classification Request process. This process allows CDRH to grant premarket approval for new devices for which there is no legally marketed predicate device as a newly classified Class I or II device using a risk-based evaluation. Sponsors
- [CDRH Guidance Schedule for FY2019](https://krogersconsulting.com/uncategorized/cdrh-guidance-schedule-for-fy2019/) - CDRH has published a list of guidance documents that the division intends to publish or review in FY2019. There are 3 separate parts to the list:The “A list”, guidance documents that the division intends to publish,The “B list”, guidance that will be published as resources permit, andThe Retrospective Review list, selected final guidance issued from
- [Genetic Testing to Predict Medication Response](https://krogersconsulting.com/uncategorized/genetic-testing-to-predict-medication-response/) - – what has and hasn’t been reviewed and approved Genetic testing to enhance patient outcomes is a hot topic in the news this year, and the FDA plays a role in reviewing and approving such tests for use. Some of the claims made by providers have not been reviewed by the agency, which resulted in
- [MRD as a Biomarker in Clinical Trials for Leukemia](https://krogersconsulting.com/uncategorized/mrd-as-a-biomarker-in-clinical-trials-for-leukemia/) - – draft guidance comment period ends 15DEC2018Interested parties have about a month to comment on the draft guidance for those planning to use minimal residual disease (MRD) as a biomarker in oncology clinical trials for treatment of blood diseases. Released in October, the guidance discusses how MRD was developed and validated, the challenges presented by
- [Read more about the ASCA Pilot Program](https://krogersconsulting.com/uncategorized/read-more-about-the-asca-pilot-program/) - The Accreditation Scheme for Conformity Assessment (ASCA) is a program being developed by CDRH to reduce the number of sponsor questions in areas where the agency has observed inconsistent practices with respect to testing and conformance declarations. These inconsistent practices have then led to inconsistencies and inefficiencies in the review process.See my previous consensus standards
- [Public Opinion Wanted on Software for Use with Prescription Drugs](https://krogersconsulting.com/uncategorized/public-opinion-wanted-on-software-for-use-with-prescription-drugs/) - The FDA has posted a Request for Comments to better understand how to regulate software developed by drug sponsors for use with their prescription drugs (Docket No. FDA-2018-N-3017). The request notes that sponsors who have been developing software apps to market with a particular drug product have asked the FDA for clarity on the regulation
- [Source Code and Technical Documents for a Clinical Trials App](https://krogersconsulting.com/uncategorized/source-code-and-technical-documents-for-a-clinical-trials-app/) - In early November, the FDA announced they were releasing the open source code and technical information for their MyStudies app. This app was developed and piloted by the FDA as a way for patients enrolled in a clinical trial to enter their own health data which would be matched with the electronic health record data
- [Next Generation Sequencing – will it work for MRD?](https://krogersconsulting.com/uncategorized/next-generation-sequencing-will-it-work-for-mrd/) - In an earlier post I noted that pathology experts believe next generation sequencing will be required to bring minimal residual disease (MRD) into focus as a more valuable endpoint for clinical trials of leukemia treatments. I’ve reviewed the technique, which starts with a bone marrow sample from which the laboratory isolates the DNA, increases the
- [Katrina's Reading List](https://krogersconsulting.com/uncategorized/katrinas-reading-list/) - Understanding How We Make Decisions Many people ask me for professional advice on making a decision, to which question there is seldom a short answer. To prepare for such questions, I recommend reading widely about the science behind our decision-making processes. Some books I’ve found useful include: “Thinking Fast and Slow” by Daniel Kahnemann –
- [The Orange Book is Available as an App](https://krogersconsulting.com/uncategorized/the-orange-book-is-available-as-an-app/) - The Orange Book is the common name for the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations”. This reference work contains lists of drug products approved by the FDA, and its purpose is to enable providers and patients find substitute drugs that are therapeutically equivalent to a name brand drug. The lists include both
- [How to Complete Form FDA 3602:](https://krogersconsulting.com/uncategorized/how-to-complete-form-fda-3602/) - MDUFA Small Business Qualification and Certification for a Business Headquartered in the United StatesQualifying as a small business with the FDA gives a company a substantial discount in the user fees required under the Medical Device User Fee Amendments (MDUFA). Businesses can qualify if they can prove their gross receipts are less than $100 million
- [47 New Medical Devices Approved under PMAs and HDEs in 2018](https://krogersconsulting.com/uncategorized/47-new-medical-devices-approved-under-pmas-and-hdes-in-2018/) - – Approvals Occurred Between 21DEC2017 and 18SEP2018Each year the FDA publishes data on the devices receiving approval through the various submission pathways. References to much of this information are available in several locations including the Federal Register. In mid-November, the agency published a list of the new devices receiving PMA or HDE approval announced since
- [Table of Surrogate Endpoints Published by the FDA](https://krogersconsulting.com/uncategorized/table-of-surrogate-endpoints-published-by-the-fda/) - Per the requirements in the 21st Century Cures Act, the FDA has published this month the first ever “Table of Surrogate Endpoints That Were the Basis of Drug Approval or Licensure”. Surrogate endpoints (SEs, not to be confused with Substantial Equivalence for medical devices) are measures that are known to predict a clinical benefit that
- [The PSTC/FNIH Kidney Safety Biomarker](https://krogersconsulting.com/uncategorized/the-pstc-fnih-kidney-safety-biomarker/) - - is a good example of the requirements for qualification under the Biomarker Qualification ProgramThere is considerable public interest in using biomarkers (measurements of substances present in the body or physical health parameters such as blood pressure or changes in pupil size) as a way to diagnose disease and evaluate medical product safety in clinical
- [The FDA Intends to Promote Modern Predicate Devices for 510(k)s](https://krogersconsulting.com/uncategorized/the-fda-intends-to-promote-modern-predicate-devices-for-510ks/) - Part of the work in modernizing the 510(k) device approval pathway, first established by congressional amendment of the FD&C Act in 1976 and updated in subsequent amendments, is an examination of how comparison of new devices to older (predicate) devices promotes patient safety. The 510(k) pathway is used for the majority of device submissions, and
- [CDER Researchers are Investigating Mass Spectrometry](https://krogersconsulting.com/uncategorized/cder-researchers-are-investigating-mass-spectrometry/) - - for QC of Protein DrugsMass spectrometry has been a critical tool for drug discovery and development since the advent of atmospheric pressure ionization sources (ESI and APCI) in the 1980s. As a mass spectrometry expert, I have been looking forward to the move of this technology into quality control for many years. Researchers at
- [The ClinGen Clinical Genome Resource](https://krogersconsulting.com/uncategorized/the-clingen-clinical-genome-resource/) - Is the First Genetic Variants Database to be Recognized by the FDAOn December 4, 2018, the FDA announced recognition of the ClinGen Clinical Genome Resource as a resource for clinicians and developers of genetic tests. This database is the first genetic variants database to be recognized by the FDA per the guidance “Use of Public
- [Draft Guidance on CLIA Waivers](https://krogersconsulting.com/uncategorized/draft-guidance-on-clia-waivers/) - In late November the FDA released two draft guidance documents addressing manufacturer applications for Clinical Laboratory Improvement Amendments (CLIA) waivers for the in vitro diagnostic (IVD) devices. These draft guidance documents propose updates to the 2008 CLIA Waiver Guidance to meet the updated requirements approved in the 21st Century Cures Act. These documents areSelect Updates
- [Wishing you a Peaceful and Prosperous New Year](https://krogersconsulting.com/uncategorized/wishing-you-a-peaceful-and-prosperous-new-year/) - I have many interesting topics and ideas to share with you in 2019, including new ways to look at device approvals, some new reading lists, and posts on topics as varied as data integrity, clinical trials design, and medical software apps. Have a wonderful new year!Text Copyright © 2019 Katrina Rogers
- [Consulting with FDA on Use of Novel Surrogate Endpoints](https://krogersconsulting.com/uncategorized/consulting-with-fda-on-use-of-novel-surrogate-endpoints/) - In a recent issue of SBIA Chronicles, the agency is encouraging sponsors to request type C meetings early in the development process when they plan to use novel surrogate endpoints (SE) as primary measures of efficacy in trials for a new drug. These SE are biomarkers that have not previously been used as the primary
- [Involvement of Payors in Pre-Submission Discussions](https://krogersconsulting.com/uncategorized/involvement-of-payors-in-pre-submission-discussions/) - – For New Medical DevicesPatients whose insurance policies don’t cover innovative new treatments are often excluded from treatments that could be beneficial because they can’t afford them. The FDA is working on approaches to minimize the delay between approval and recognition by health insurance companies for a new medical device. The agency has operated the
- [Merry Christmas and Happy New Year](https://krogersconsulting.com/uncategorized/merry-christmas-and-happy-new-year/) - I'd like to wish for all my readers to have the merriest holiday and a peaceful and prosperous new year. I'll have a new post for you after Christmas. Text Copyright © 2018 Katrina Rogers
- [New Rules for Classification of Medical Devices](https://krogersconsulting.com/uncategorized/new-rules-for-classification-of-medical-devices/) - In December the FDA issued two rules that will affect the classification and reclassification of medical devices. The first rule, which will become final on 18MAR2019, the agency is amending 21 CFR Part 860 to establish new processes for PMA applications for preamendments devices and reclassification of devices. Under the new process, the agency would
- [Impact of Reducing Regulation of Non-Device Software Functions](https://krogersconsulting.com/uncategorized/impact-of-reducing-regulation-of-non-device-software-functions/) - In December, the FDA issued their first report on the impact of changes to the regulation of non-device software functions under the 21st Century Cures Act. These changes removed certain software functions from the definition of a medical device in the amended FD&C Act. These software functions are:administrative support of a health care facility;maintaining or
- [Changing the Manufacturing Site for a Device](https://krogersconsulting.com/uncategorized/changing-the-manufacturing-site-for-a-device/) - Guidance on When and What to File for Holders of PMAs/HDEs/IDEsCDRH and CBER have issued a new guidance clarifying the definitions of changes to a manufacturing site for medical devices and giving clearer instructions on what type of supplement to file for each type of change. The agency’s thinking on changes to device manufacturing sites
- [FDA publishes Framework for Real World Evidence (RWE)](https://krogersconsulting.com/uncategorized/fda-publishes-framework-for-real-world-evidence-rwe/) - In early December the FDA published their Framework for Real World Evidence (RWE) Program. The intent of the program is to allow the agency to work with sponsors to evaluate the use of RWE to support approval of new indications or satisfy post-approval study requirements for approved drugs and biological products. The RWE program is
- [Biomarker Qualification Evidentiary Framework Draft Guidance](https://krogersconsulting.com/uncategorized/biomarker-qualification-evidentiary-framework-draft-guidance/) - The 21st Century Cures Act added a section to the FD&C Act to promote the qualification of drug development tools, including the qualification of biomarkers for use in drug development. Readers will recall my previous post on the FDA’s biomarker qualification program including an example of a qualified biomarker. To enhance the program, CDER and
- [CDER’s 2018 New Drug Therapy Approvals](https://krogersconsulting.com/uncategorized/cders-2018-new-drug-therapy-approvals/) - In early January, CDER released its report on the 59 new drug therapies approved in calendar year 2018. Among the new drugs approved last year are treatments for rare diseases like phenylketonuria, the first in a new class of drugs to treat non-responding HIV-1 patients, and a host of new and more selective cancer treatments.
- [The Software Pre-Certification Pilot Program Takes Another Step](https://krogersconsulting.com/uncategorized/the-software-pre-certification-pilot-program-takes-another-step/) - Part 1 of 2The FDA has recognized that the current regulatory pathways for Software as a Medical Device (SaMD) do not let them assess the safety and effectiveness of new SaMD products at the pace of modern software development. This fact likely limits the availability of new software applications that could significantly benefit patients. The
- [Q&A Guidance for Data Integrity](https://krogersconsulting.com/uncategorized/qa-guidance-for-data-integrity/) - Data integrity continues to be a top observation during FDA inspections, with many observations leading to significant regulatory actions (warning letters, import alerts, and consent decrees). To help companies comply with expectations, the FDA has issued a new guidance document. The guidance cites the specific requirements for data integrity from 21CFR parts 210, 211, and
- [Strategic Plans for Post-Market Safety Surveillance at FDA](https://krogersconsulting.com/uncategorized/strategic-plans-for-post-market-safety-surveillance-at-fda/) - The primary tool used by the FDA for drug post-market safety surveillance is the Sentinel System. This system, authorized in 2007 in the FDA Amendments Act, started with a pilot in 2009 and as of 2016 is a fully operational tool for linking and analyzing safety data from multiple sources. The system includes the capability
- [Pre-IND Meeting FAQ](https://krogersconsulting.com/uncategorized/pre-ind-meeting-faq/) - Let’s say your company has a new drug with some exciting discovery and animal data, and you are planning for clinical development, including the Investigational New Drug (IND) application with the FDA. Do you have questions about the advisability and feasibility of a pre-IND meeting for your new drug? CDER SBIA created a website to
- [Patient Focused Drug Development Draft Guidance](https://krogersconsulting.com/uncategorized/patient-focused-drug-development-draft-guidance/) - Patient focused drug development is a recent interest at the FDA following the adoption of the 21stCentury Cures Act. Sections 3001 to 3004 of this act add the definition of patient experience data to the FD&C Act and tells the FDA how to work with sponsors using patient experience data for drug and biological submissions.
- [Breakthrough Devices Program](https://krogersconsulting.com/uncategorized/breakthrough-devices-program/) - The final guidance for the Breakthrough Devices Program was issued by the FDA in December 2018. Under this program (part of the changes to the FD&C Act created by passage of the 21stCentury Cures Act), sponsors of devices or device-led combination products that “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating
- [Paul Gibbon’s Best Non-Fiction Books of 2018](https://krogersconsulting.com/uncategorized/paul-gibbons-best-non-fiction-books-of-2018/) - Readers will remember my recommendation for Paul Gibbon’s book “The Science of Successful Organizational Change” from a previous post. Paul published his list of the best non-fiction books of 2018 in early January, and I believe the list deserves serious consideration for our reading lists this year. I have already read Stephen Pinker’s “Enlightenment Now:
- [Modernizing the 510(k) Program](https://krogersconsulting.com/uncategorized/modernizing-the-510k-program/) - Focus on the Total Product Life Cycle and Promoting Newer Predicate DevicesIn April 2018 the FDA published the Medical Device Safety Action Plan in which the agency first described its current framework for ensuring both existing and new medical devices are safe and effective as well as previous program enhancements that are based on a
- [CDRH Device Review Process Management Assessment](https://krogersconsulting.com/uncategorized/cdrh-device-review-process-management-assessment/) - In December, CDRH published a report by consultant group Booz Allen Hamilton evaluating the results of the plans established by CDRH to improve the medical device review process. These plans were based on the recommendations from phase 1 of the assessment (also performed by Booz Allen) on the best practices and improvements that would promote
- [What Are All These Device Review and Approval Pathways? Part 4](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-4/) - Abbreviated 510(k)sThe third type of premarket notification available under the New 510(k) paradigm is the Abbreviated 510(k). This notification was originally authorized for use on a modified device when there exists an issued guidance, an established special control (for example, performance standards, postmarket surveillance, or patient registries), or a consensus standard to which the sponsor
- [What Are All These Device Review and Approval Pathways? Part 3](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-3/) - The Special 510(k)Under the New 510(k) paradigm (the guidance was published in 1998, so it’s hardly that new), there are 3 ways that sponsors may file a premarket notification for their device. Page 11 of that guidance document contains a flow chart that may help sponsors choose which way to file. The Traditional 510(k), discussed
- [Authorization of Emergency Use for an In Vitro Diagnostic Device](https://krogersconsulting.com/uncategorized/authorization-of-emergency-use-for-an-in-vitro-diagnostic-device/) - For Ebola Virus Detection in Response to the Latest OutbreakThe FDA published a notice in the Federal Register on 13FEB2019 authorizing the emergency use of an in vitro diagnostic device (IVDD) manufactured by Chembio Diagnostic Systems, Inc. This authorization is a direct response to the Ebola virus outbreak in the Democratic Republic of the Congo
- [What Are All These Device Review and Approval Pathways? Part 2](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-2/) - The 510(k) Pathway for Premarket Notification The 510(k) pathway is a premarket approval application process authorized under section 510(k) of the FD&C Act. This type of application is required for all classes of devices that either don’t require a PMA application or are exempt from 510(k) requirements in the FD&C Act. As mentioned in my previous
- [What Are All These Device Review and Approval Pathways? Part 1](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-1/) - Classification Leads to PathwayIt can be pretty confusing to look at the medical device regulations to figure out how to submit the appropriate documentation for review, particularly in the light of the many new device programs and guidance being announced monthly. Some of this confusion stems from the history of medical device regulations. Before 1976,
- [Today is Rare Disease Day](https://krogersconsulting.com/uncategorized/today-is-rare-disease-day/) - The last day of February is designated Rare Disease Day, a campaign to raise awareness of rare diseases and their impact on patients, caregivers, and society. On this day local organizations host events to improve public knowledge of rare diseases and advocate for improved treatments and other lifestyle interventions. Check out the Rare Disease day
- [What Are All These Device Review and Approval Pathways? Part 6](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-6/) - Premarket ApprovalMost devices categorized as Class III (devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury) are required to go through the full process of scientific and regulatory review under the Premarket Approval (PMA) pathway. To
- [What Are All These Device Review and Approval Pathways? Part 5](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-5/) - Strengthening the 3rd Party 510(k) Review ProgramThe 3rd Party (3P) Review Program is an alternative process for manufacturers of medical devices to speed decisions on premarket applications for low- to moderate-risk and less complex medical devices. Under the program described in the draft guidance, the sponsor contracts with a CDRH-approved third party organizations (3PO) who
- [Draft Guidance on Rare Disease Drug Development](https://krogersconsulting.com/uncategorized/draft-guidance-on-rare-disease-drug-development/) - The CDER/CBER divisions of the FDA released a draft guidance in February 2019 describing various approaches to addressing challenges common in rare disease drug development. This latest guidance focuses on issues faced by sponsors in clinical trials; issues in early drug development/pre-IND are discussed in a draft guidance issued last year. The latest guidance discusses
- [Scott Gottlieb Stepping Down as Head of the FDA](https://krogersconsulting.com/uncategorized/scott-gottlieb-stepping-down-as-head-of-the-fda/) - The announcement on March 5th (in a staff letter which was shared on Twitter) that Scott Gottlieb, Commissioner of the FDA, would resign at the end of the month has created considerable speculation in the press. Along with questions about why (Dr. Gottlieb gave family and commute home as his reasons to step down) there
- [Devices Exempted from Premarket Notification Requirements](https://krogersconsulting.com/uncategorized/devices-exempted-from-premarket-notification-requirements/) - Not all class I or II medical devices are required to undergo a premarket notification process with the FDA. Additionally, certain preamendment unclassified devices are considered to be sufficiently well understood that they, too, do not require premarket notification. Under the 21st Century Cures Act, FDA was given the authority to exempt class II and
- [What Are All These Device Review and Approval Pathways? Part 8](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-8/) - Humanitarian Device ExemptionA rare disease is defined in the Orphan Drug Act (ODA) of 1984 as a disease or condition that affects fewer than 200,000 people in the United. Because so few patients are affected, it can be difficult to gather enough clinical evidence for a drug or medical device to demonstrate safety and effectiveness
- [What Are All These Device Review and Approval Pathways? Part 7](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-7/) - De NovoThe DeNovo Classification process has yet to be established in the regulations, though it was added to the FD&C Act in 1997 and further updated in subsequent amendments. A proposed rule for the DeNovo process was published in early December 2018 and will be open for public comment until 07MAR2019. The De Novo process
- [What Are All These Device Review and Approval Pathways? Part 9B](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-9b/) - Clinical Studies for Significant and Nonsignificant Risk Medical DevicesAn IDE is required for all medical devices that are considered significant risk devices. Guidance is available for sponsors and IRBs on what constitutes a significant risk device. Under the guidance, a significant risk (SR) device:“Is intended as an implant and presents a potential for serious risk
- [What Are All These Device Review and Approval Pathways? Part 9A](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-9a/) - Investigational Device ExemptionMost PMAs and a small percentage of 510(k)s require clinical data to support the application. Good Clinical Practice (GCP) regulations apply to any clinical study of a device, whether that devices poses a significant risk (SR) or not (NSR) (see this guidance on the definitions of SR and NSR). In order to collect
- [Haven is the New Name of the ABC Healthcare Startup](https://krogersconsulting.com/uncategorized/haven-is-the-new-name-of-the-abc-healthcare-startup/) - If you share my interests, you have been following the news about the Amazon/Berkshire Hathaway/JP Morgan & Chase (often referred to as ABC) collaboration to find ways to change the experience of health care for patients, providers, and companies. The company has taken another step forward this past week with the announcement of their new
- [Physiologically Based Pharmacokinetic Modeling](https://krogersconsulting.com/uncategorized/physiologically-based-pharmacokinetic-modeling/) - In Drug Development CDER published a survey article in February 2019 giving a capsule description of the application of Physiologically Based Pharmacokinetic Modeling (PBPM) in modern drug development. The article presents one of the nicest visuals for PBPM I’ve seen and goes on to describe the work of CDER pharmacologists to use these predictive models
- [Clinical Immunogenicity Testing of Therapeutic Proteins](https://krogersconsulting.com/uncategorized/clinical-immunogenicity-testing-of-therapeutic-proteins/) - Guidance for Development of Anti-Drug Antibody TestsA fairly common event with therapeutic proteins is the generation of immune responses to the therapy or related proteins by the patient’s immune system. These immune responses have the potential to affect product pharmacokinetics, pharmacodynamics, safety, and efficacy. Their high variability, ranging from no detectable effect to an extremely
- [Microengineered Organ Systems for Toxicology Predictions](https://krogersconsulting.com/uncategorized/microengineered-organ-systems-for-toxicology-predictions/) - CDER researchers are working on approaches to predict drug effects on human systems before clinical trials start. My earlier post on Physiological Based Pharmacokinetic Modeling discusses one such approach used for predicting human systemic exposure following dose administration of the candidate drug. Last fall the agency posted a story about the use of microengineered organ
- [What Are All These Device Review and Approval Pathways? Part 10](https://krogersconsulting.com/uncategorized/what-are-all-these-device-review-and-approval-pathways-part-10/) - The Breakthrough Devices ProgramDevices and device-led combination may be eligible for enhanced access to reviewers and priority review through the Breakthrough Devices program if they meet the program criteria:The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, andThe device meets at least one of the following:Represents Breakthrough
- [Premarket Review Pathways for Combination Products](https://krogersconsulting.com/uncategorized/premarket-review-pathways-for-combination-products/) - Combination products are medical products composed of 2 or more different types of individual medical products; for example, a drug plus dosing device (think of asthma inhalers or prefilled syringes) or a drug plus the solution needed to reconstitute it for dosing (think of a vaccine). Combination products are reviewed by a team led by
- [Facility Shutdown May Impact Supply of Medical Devices](https://krogersconsulting.com/uncategorized/facility-shutdown-may-impact-supply-of-medical-devices/) - Earlier this year, the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The state EPA order was due to the presence of levels of ethylene oxide higher than the EPA
- [CDRH is Reorganizing This Year](https://krogersconsulting.com/uncategorized/cdrh-is-reorganizing-this-year/) - The FDA’s Center for Devices and Radiological Health (CDRH) is reorganizing this year to better integrate the center’s premarket and postmarket program functions and optimize decision making across the total life cycle of medical devices. The new organization will be aligned by the type of product being regulated. This will allow reviewers, compliance officers and
- [New Guidances to Broaden Cancer Trial Eligibility Criteria](https://krogersconsulting.com/uncategorized/new-guidances-to-broaden-cancer-trial-eligibility-criteria/) - The FDA’s Oncology Center of Excellence (OCE) in cooperation with CDER and CBER has released several new guidances intended to broaden the eligibility criteria for cancer clinical trials. A trial’s eligibility criteria define the patient population studied in the trial, and some patients with conditions covered by the guidances (HIV, HBV, HCV, organ dysfunction, prior
- [Draft Guidance for Food Effect and Bioavailability Studies](https://krogersconsulting.com/uncategorized/draft-guidance-for-food-effect-and-bioavailability-studies/) - This February CDER issued draft guidance for clinical studies on the effects of food administration on and bioavailability of orally administered drug products. The bioavailability guidance also applies to drug products where systemic exposure measurements are appropriate for bioavailability measurements (such as drugs with transdermal delivery systems). Both guidance are intended for sponsors submitting data
- [The National Evaluation System for Health Technology = Device RWE](https://krogersconsulting.com/uncategorized/the-national-evaluation-system-for-health-technology-device-rwe/) - A clear understanding the total product life cycle of a medical device requires much more data than is available in routine regulatory submissions. The FDA has recognized that a national system to collect and analyze Real World Data (RWD) and convert it to Real World Evidence (RWE) would provide a body of information that patients
- [What is REMS?](https://krogersconsulting.com/uncategorized/what-is-rems/) - The acronym REMS stands for Risk Evaluation and Mitigation Strategy, a component of approval that may be required when the FDA determines that additional information beyond prescribing information is necessary to ensure that the benefits of a drug outweigh its risks. Authorized under section 505-1 of the FD&C Act, a REMS may include any or
- [Proposal for Modernizing the 510(k) Program Appears Controversial](https://krogersconsulting.com/uncategorized/proposal-for-modernizing-the-510k-program-appears-controversial/) - Proposal Comment Period ExtendedOn April 11ththe FDA extended the comment period for call for comments on how to shift industry and agency focus towards the development and use of more modern predicate devices for determinations of Substantial Equivalence (following the Medical Device Safety Action Plan; see my previous post for details). The docket will be
- [Cybersecurity is a Concern for the FDA](https://krogersconsulting.com/uncategorized/cybersecurity-is-a-concern-for-the-fda/) - In case you haven’t noticed, cybersecurity for medical devices is a subject of concern for the FDA. The issue has been clarified this week by the announcement of cybersecurity vulnerabilities affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors. The devices are implanted cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds), devices that provide
- [Monitoring Clinical Trials for Drug Safety Issues](https://krogersconsulting.com/uncategorized/monitoring-clinical-trials-for-drug-safety-issues/) - On March 21, 2019 the FDA issued an alert about the risks associated with the investigational use of Venclexta (venetoclax) for the treatment of patients with multiple myeloma. The alert is based on review of data from the Bellini clinical trial (NCT02755597, Study M14-031) evaluating the use of Venclexta combined with bortezomib, a proteasome inhibitor,
- [Don’t Miss the FDA Regulatory Education for Industry Conference](https://krogersconsulting.com/uncategorized/dont-miss-the-fda-regulatory-education-for-industry-conference/) - It's Available Virtually in Late MayCDER and CDRH are hosting the annual Regulatory Education for Industry conference on May 29-30th. Attendees may participate in person at the The Revere Hotel in Boston, MA or virtually using Adobe Connect, and the event registration is free (though in person registrations are limited to 300). There are 2
- [Artificial Intelligence (AI)/Machine Learning (ML) Based Software](https://krogersconsulting.com/uncategorized/artificial-intelligence-ai-machine-learning-ml-based-software/) - The FDA Proposes a Quality System Regulatory Framework for Modifications to AI/ML Software as a Medical Device (SaMD)A discussion paper was posted this month to request feedback on a proposed regulatory framework for AI/ML SaMD. The current regulatory framework is expressed in the guidance "Deciding When to Submit a 510(k) for a Software Change to
- [Guidance on Rare Disease Natural History Studies](https://krogersconsulting.com/uncategorized/guidance-on-rare-disease-natural-history-studies/) - This March, CDER, CBER, and the Office of Orphan Products (OOP) issued a draft guidance describing their current thinking on the performance of natural history studies. This type of study is used to collect information on the course of a particular disease and to identify demographic, genetic, environmental, and treatment variablesthat correlate with the disease’s
- [Pharmaceutical Quality Systems and Established Conditions](https://krogersconsulting.com/uncategorized/pharmaceutical-quality-systems-and-established-conditions/) - The product lifecycle is a well-known concept in quality circles that is finding increasing use in the pharmaceutical and medical device community. Key to the understanding of a product are the elements of Chemistry, Manufacturing and Controls (CMC) [description, manufacturing process, facilities and equipment, and associated control strategy] that assure process performance and quality. These
- [Updates to the FDA’s Web Page May Mean Broken Links in Posts](https://krogersconsulting.com/uncategorized/updates-to-the-fdas-web-page-may-mean-broken-links-in-posts/) - I’ve recently noticed some updates to the FDAs web pages that may mean some broken links in my previous posts. When you click on some links, you will see the notification shown above (see an example by clicking here). I’ve been able to find the resources by copying keyword text from my posts and using
- [CDRH forms the Office of Product Evaluation and Quality](https://krogersconsulting.com/uncategorized/cdrh-forms-the-office-of-product-evaluation-and-quality/) - Readers will recall my previous post on the reorganization of CDRH to create a more adaptive structure to meet future needs. As part of that reorganization, the Office of Product Evaluation and Quality (OPEQ) was launched on May 1st, 2019 (see the announcement here). The announcement provides some practical examples of how the new structure
- [The Life Science Innovation Northwest Conference](https://krogersconsulting.com/uncategorized/the-life-science-innovation-northwest-conference/) - Medical Products in the NorthwestLast week’s Life Science Innovation Northwest conference offered a diverse look at the research and commercialization of medical products (both pharmaceuticals and medical devices) currently underway in the Pacific Northwest. Attendees arrived in Seattle from across the West Coast and the U.S. and engaged in 2 days of panel presentations, individual
- [MDEpiNet and the Women’s Health Coordinated Registry Network](https://krogersconsulting.com/uncategorized/mdepinet-and-the-womens-health-coordinated-registry-network/) - One goal of the FDA’s Medical Device Safety Action Plan (see my previous post on the plan) is to support an improved national medical device evaluation and surveillance system. The Medical Device Epidemiology Network (MDEpiNet) is a public-private partnership established to build and operate that national device ecosystem. One of its projects, the Women’s Health
- [IVDDs for Detection of Bacillus Species are Class II Devices](https://krogersconsulting.com/uncategorized/ivdds-for-detection-of-bacillus-species-are-class-ii-devices/) - On April 1st, the FDA issued a final rule that classifies In Vitro Diagnostic Devices (IVDD) for Bacillus Species Detection as class II devices requiring premarket notification through the 510(k) review process. The purpose of this type of device is to detect and differentiate among Bacillus species for diagnosis in a clinical setting with particular
- [What are the Least Burdensome Approach for Medical Devices?](https://krogersconsulting.com/uncategorized/what-are-the-least-burdensome-approach-for-medical-devices/) - CDRH hosted a webinar on March 14th to review the current state of the Least Burdensome approach following issuance of an updated final guidance on February 5, 2019. The purpose of the approach is the remove or reduce unnecessary burden during the regulatory process while still meeting the statutory requirements for clearance and approval. The
- [Patient Preference Information for Medical Devices](https://krogersconsulting.com/uncategorized/patient-preference-information-for-medical-devices/) - Patient Preference Information (PPI) is one type of patient feedback that provides assessments of the desirability or acceptability of different treatment alternatives. This information shows the value attributed to different aspects of each alternative and it can be used to add a patient perspective to the treatment’s risk/benefit assessment. CDRH uses patient preference information on
- [Development and Submission of Near IR Analytical Procedures](https://krogersconsulting.com/uncategorized/development-and-submission-of-near-ir-analytical-procedures/) - Draft guidance was issued in March on the development and submission of near infrared (NIR) analytical procedures for use during the manufacture and analysis of pharmaceuticals. NIR is a spectroscopic technique that uses wavelengths of light just below the visible spectrum (typically between 700-800 nm) to measure materials for either identity or concentration. It’s been
- [Draft Guidance on Pediatric Nonclinical Safety Testing](https://krogersconsulting.com/uncategorized/draft-guidance-on-pediatric-nonclinical-safety-testing/) - Last September the International Council for Harmonization (ICH) released its draft guideline "Nonclinical Safety Testing in Support of Development of Paediatric Medicines – S11” to provide direction on safety studies required to support the development of pediatric medicines. The FDA is an active member in the ICH and published a copy of the ICH guidance
- [Ebook “Process Improvement Using Data”](https://krogersconsulting.com/uncategorized/ebook-process-improvement-using-data/) - Practitioners of quality rely on data to determine root causes and devise effective solutions and process improvements. There are many resources available on the subject, but few are free, and rarely do we find a free resource that is as clear, usable, and entertaining as “Process Improvement Using Data” by Kevin Dunn. Mr. Dunn was
- [Did You Know CDRH Regulates Laser Illuminated Projectors?](https://krogersconsulting.com/uncategorized/did-you-know-cdrh-regulates-laser-illuminated-projectors/) - I was reminded this month that the FDA is the regulatory body for a wide variety of radiation-emitting products available in the U.S. when I received this notice of the final guidance "Classification and Requirements for Laser Illuminated Projectors”. That’s right, this is guidance for projectors that use lasers instead of conventional lamps for illumination.
- [The User Experience is Critical to Software Success](https://krogersconsulting.com/uncategorized/the-user-experience-is-critical-to-software-success/) - Why Isn’t this Obvious?I participated in a commercial webinar last week about improving clinical trial data acquisition, patient participation, and treatment compliance using mobile applications with a thoughtfully designed user experience (UX). The presenters discussed 3 relevant case studies from other industries and their experience applying the lessons from those case studies to mobile clinical
- [Help FDA Track RWE by Identifying Its Use in Drug Submissions](https://krogersconsulting.com/uncategorized/help-fda-track-rwe-by-identifying-its-use-in-drug-submissions/) - In a previous post I discussed the FDA’s Framework for Real World Evidence program. The latest update to this program is a draft guidance intended to encourage sponsors submitting INDs, NDAs, and BLAs that use Real World Evidence (RWE) to support a regulatory decision on safety or effectiveness to self-identify those studies that use RWE.
- [The Device Standards and Conformity Assessment Program](https://krogersconsulting.com/uncategorized/the-device-standards-and-conformity-assessment-program/) - In a previous post, I discussed guidance on how the FDA intends to use consensus standards to facilitate review of device submissions. Consensus help device manufacturers simplify their submissions using documented evidence that their devices conform to those standards recognized by the agency.The FDA maintains a program to provide information on how to use standards,
- [New CDER FDA-TRACK web page](https://krogersconsulting.com/uncategorized/new-cder-fda-track-web-page/) - In late May CDER launched a new web page for their portion of FDA-TRACK, the performance management system used by the FDA to monitor the agencies’ programs. The new web page provides business intelligence and analytics for the division using 7 dashboards:Policy and Science DevelopmentDrugs and Biologics (Pre-Approval)Biosimilars (Pre-Approval)Generics (Pre-Approval)Drug Shortages (Post-Approval)Compliance (Post-Approval)Patient Safety Tools
- [LSW East/West Summit focused on Neuroscience in the Northwest](https://krogersconsulting.com/uncategorized/lsw-east-west-summit-focused-on-neuroscience-in-the-northwest/) - It was a thought-provoking day last Thursday at the Life Science Washington East/West Life Science Summit. After hearing Amy Bernard’s call for collaboration with the Allen Institute for Brain Science, we participated in a discussion of neuroscience innovation at Washington State University, including the introduction of the newly formed Steve Gleason Institute for Neuroscience. Leaders
- [Join Us Today at the LSW East/West Summit](https://krogersconsulting.com/uncategorized/join-us-today-at-the-lsw-east-west-summit/) - Readers in an around Spokane today should consider joining us to learn more about neuroscience research and development in Eastern Washington at the Life Science Washington East/West Life Science Summit. The conference started with a networking event last night and will run from 7:30 am - 2:30 pm today at the Historic Davenport Hotel in
- [Producing a Generic Drug is Not Easy](https://krogersconsulting.com/uncategorized/producing-a-generic-drug-is-not-easy/) - At first glance, one might think that copying an innovator drug to produce a generic drug would be pretty simple. Most of the development work has already been done, and the generics producer only has to copy that information and receive approval for an Abbreviated New Drug Application (ANDA) from the FDA. That simple assessment
- [Branded Apps for Real World Data Collection in the MyStudies API](https://krogersconsulting.com/uncategorized/branded-apps-for-real-world-data-collection-in-the-mystudies-api/) - The FDA released the code and technical documentation for their MyStudies Platform last November and hosted a full day of webinars in early May to orient developers on the system. All the webinars and complete documentation for the system may be found at this SBIA web page. The platform may be used and modified for
- [Call to Participate in 2019 Pre-Cert Test Plan](https://krogersconsulting.com/uncategorized/call-to-participate-in-2019-pre-cert-test-plan/) - Digital Health Software Precertification (Pre-Cert) Program – part 3On May 22 the FDA posted a call for test cases to participate in the 2019 Digital Health Software Precertification (Pre-Cert) Program Test Plan (see my previous post here). They are looking for volunteers who expect to submit traditional 510(k) marketing submissions in 2019 and are representative
- [Mining U.S. Census Data for your Business](https://krogersconsulting.com/uncategorized/mining-u-s-census-data-for-your-business/) - As business leaders, scientists, and entrepreneurs, we are often looking for data to help us make a business case, understand social situations, and scope the feasibility of a new idea. The U.S. government collects a wide range of data through the Census Bureau that can be used for these purposes, but how do we know
- [Draft Guidance on Master Clinical Trial Protocols](https://krogersconsulting.com/uncategorized/draft-guidance-on-master-clinical-trial-protocols/) - Expediting Development of Oncology TherapeuticsConferees at the American Association of Cancer Research in March had the chance to hear about master clinical trial protocols from Marc Theoret, who is the Lead Medical Officer in the Office of Oncology Drug Products at CDER. Master clinical trial protocols is a concept promoted by the FDA in a
- [Summer Slow Down](https://krogersconsulting.com/uncategorized/summer-slow-down/) - Dear Readers:As summer starts, I’ll be reducing the frequency of my posts to give me a bit of extra time for some fun. Look for my updates twice a week (on Tuesdays and Thursdays) and be sure to contact me if you have a topic you’d like me to look into.Katrina
- [Patient Reported Outcomes Measures in Medical Device Submissions](https://krogersconsulting.com/uncategorized/patient-reported-outcomes-measures-in-medical-device-submissions/) - Regular readers will recall my previous post on framework for Real World Data (RWD)/Real World Evidence (RWE) and its potential role(s) in drug approvals. Patient-Reported Outcomes Measures (PROM) can fill a similar role in medical device submissions. A PROM is a instrument or tool, typically a questionnaire or diary, used to gather the health status
- [What’s the Difference Between a Pre-Sub and a Q-Sub?](https://krogersconsulting.com/uncategorized/whats-the-difference-between-a-pre-sub-and-a-q-sub/) - The FDA’s Pre-Submission (Pre-Sub) program allows sponsors to request feedback from the agency on their planned medical device submissions. The original Pre-Sub guidance (issued in 2014 and updated in 2017) described 6 specific mechanisms for feedback:Pre-SubmissionsInformational MeetingsStudy Risk DeterminationsFormal Early Collaboration Meetings (i.e., Agreement and Determination Meetings) Submission Issue MeetingsPMA Day 100 MeetingsThese were collectively
- [Expanded Access Made Easier for Oncology Treatments](https://krogersconsulting.com/uncategorized/expanded-access-made-easier-for-oncology-treatments/) - On June 3rd the FDAs Oncology Center for Excellence announced the launch of a new call center known as Project Facilitate to increase access to unapproved oncology therapies for use in patients who are not eligible for the clinical trial(s) for those therapies. Readers will recall my previous post on the Expanded Access program as
- [Upcoming Public Meetings on Medical Devices](https://krogersconsulting.com/uncategorized/upcoming-public-meetings-on-medical-devices/) - The FDA has scheduled two public meetings, one in July and one in September, to obtain feedback related to medical device communications technologies. The first will be July 17th and is co-hosted by the Networking and Information Technology Research and Development Program, a federally funded group working on advanced information technologies (see their web site
- [Expanded Access Program for Medical Devices](https://krogersconsulting.com/uncategorized/expanded-access-program-for-medical-devices/) - Readers of this blog will recall my earlier posts (here and here) on expanded access programs which enable physicians of patients with critical and life-threatening conditions options to treat their patients with pre-approval medicines outside of a clinical trial setting. In a similar fashion, the medical device Expanded Access Program offers a potential pathway for
- [2019 CDER Guidance Updates](https://krogersconsulting.com/uncategorized/2019-cder-guidance-updates/) - Every year CDER publishes a list of the guidance it plans to create or revise during the year. This year’s list was published in early March and it contains a number of interesting topics. Some of these we have already discussed (like “Rare Diseases: Natural History Studies for Drug Development” (see this post) and “Survey
- [Draft Guidance on Enhancing Clinical Trial Populations](https://krogersconsulting.com/uncategorized/draft-guidance-on-enhancing-clinical-trial-populations/) - Under the FDA Reauthorization Act of 2017, the FDA received a mandate to promote practices that lead to clinical trials better reflecting the population most likely to use the drug. Based on discussions at a public meeting held in April 2018, CDER’s Office of Medical Policy issued a draft guidance in June 2019 with the
- [How to Study and Market Your Device](https://krogersconsulting.com/uncategorized/how-to-study-and-market-your-device/) - Have you been wondering how to start planning the regulatory process for your proposed medical device? CDRH offers this web page showing the 5 steps of how to study and market your device, and it’s an ideal first step for the new device sponsor. It shows the 5 steps you must follow before marketing your
- [ICH Guidance on Bioanalytical Method Validation](https://krogersconsulting.com/uncategorized/ich-guidance-on-bioanalytical-method-validation/) - Drug regulation is a global effort, with country specific agencies each with their own unique perspective on the regulatory challenges within their own borders. There is also an international group known as the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) dedicated to bringing together the regulatory authorities and pharmaceutical
- [Bioanalytical Method Validation](https://krogersconsulting.com/uncategorized/bioanalytical-method-validation/) - The FDA publishes guidance documents to aid the medical products industry and the public in understanding and applying the regulations and requirements for pharmaceutical and medical device marketing approval. Supplemental information (in the form of Q&A guidance, web pages, webinars, and other materials) is also available to help clarify particular guidance when necessary, and CDER’s
- [War Games as a Strategy Tool](https://krogersconsulting.com/uncategorized/war-games-as-a-strategy-tool/) - I just read an article in Life Science Leader about the use of war games as a strategy tool. This is not a new concept; rather, it’s just a differently structured and more formal way to think more deeply in a strategic mode with a group of up to 40 participants. For those uncomfortable with
- [How Are Citizen Petitions Used?](https://krogersconsulting.com/uncategorized/how-are-citizen-petitions-used/) - In my last post, I reviewed the new guidance on the processes available to resolve disagreements arising from official actions or decisions made by members of CDRH. One of those processes is citizen petitions, and because I was interested in how these were used, I reached out to the CDRH Ombudsman’s office (as suggested in
- [Your Options When Disagreeing with a CDRH Action or Decision](https://krogersconsulting.com/uncategorized/your-options-when-disagreeing-with-a-cdrh-action-or-decision/) - It may seem as if a negative decision on your device application is final; however, that is far from the truth. CDRH has multiple processes for resolving disputes with any external stakeholders (sponsor, industry, or public) which are included in the applicable statues and regulations. These processes are also more simply described in the recently
- [Guidance for Special Materials Used in Medical Devices](https://krogersconsulting.com/uncategorized/guidance-for-special-materials-used-in-medical-devices/) - The materials used in medical devices, particularly those which are designed to be implantable or used in invasive procedures, must be carefully evaluated for safety and that evaluation documented in the premarket submission for the device. Some materials present unique risks; therefore, CDRH creates special guidance to help sponsors evaluate their devices effectively. One such
- [Updates on Modernization of the New Drugs Regulatory Program](https://krogersconsulting.com/uncategorized/updates-on-modernization-of-the-new-drugs-regulatory-program/) - We’ve already seen several updates on the FDA’s activities to modernize their operations, including updates to the web site structure and format, the April announcement of the CDRH reorganization (see this post), and a new CDER web page for FDA-Track (see this post). In June CDER also updated the page describing their plans for modernizing
- [Preparing for Your FDA Inspection](https://krogersconsulting.com/uncategorized/preparing-for-your-fda-inspection/) - At some point on your journey to an approved drug, biologic, or medical device, you (and any contract organizations you’ve hired to help you with nonclinical, GLP, and clinical studies as well as manufacturing) will be subject to inspection by the regulatory authorities with whom you plan to file your application. The inspections help your
- [Background Research for Your IND/NDA/BLA/Market Application](https://krogersconsulting.com/uncategorized/background-research-for-your-ind-nda-bla-market-application/) - When doing your background work in preparation for a new or updated submission, it can be helpful to understand the structure, personnel and process in the FDA offices with whom you may be working. There are a number of ways you can gather this information, including the organizational structure web pages (see this previous post),
- [Where Did Former FDA Commissioner Scott Gottlieb Go?](https://krogersconsulting.com/uncategorized/where-did-former-fda-commissioner-scott-gottlieb-go/) - Regular readers will recall my post in March about the departure of FDA Commissioner Scott Gottlieb. He returned to his previous company, venture capital firm New Enterprise Associates Inc, as a Special Partner on their healthcare investment team. He’s also now a Resident Fellow of think tank American Enterprise Institute, a non-partisan organization known for
- [Drug and Biologic Labeling for Drug Abuse & Dependence Potential](https://krogersconsulting.com/uncategorized/drug-and-biologic-labeling-for-drug-abuse-dependence-potential/) - The regulations for the content and format of labeling for human prescription drug and biological products (found in 21 CFR 201.57(c)(10)) provide for a special section to convey information on a drug’s potential for abuse, misuse, addiction, physical dependence, and tolerance to health care providers. This section is known as the Drug Abuse and Dependence
- [Pharmaceutical Quality Symposium in October](https://krogersconsulting.com/uncategorized/pharmaceutical-quality-symposium-in-october/) - October is shaping up to be an excellent month for Public discussions sponsored by the FDA. The latest to be announced is a SBIR symposium on pharmaceutical product quality to be held in College Park, MD on October 16-17. The agenda covers the agencies practices for facilities and approval inspections, post-approval quality and change management,
- [Workshop on RWE in Early October](https://krogersconsulting.com/uncategorized/workshop-on-rwe-in-early-october/) - IIn a previous post, I discussed the FDAs publication of a framework for Real World Evidence (RWE) last December, and we’ve looked at its use in drug and device submissions since then. The agency, in cooperation with the Duke Margolis Center for Public Health Policy, is hosting a workshop on RWE on October 3rd in
- [Updates to the Q&A Guidance on Laboratory Controls](https://krogersconsulting.com/uncategorized/updates-to-the-qa-guidance-on-laboratory-controls/) - On August 12, 2019, the FDA updated its guidance Question and Answers on Current Good Manufacturing Practices – Laboratory Controls to add 3 new questions with answers focused on laboratory tests using chromatographic systems. This level 2 guidance presents a list of technical questions related to laboratory testing, a critical step in the process of
- [Data Integrity Guidance](https://krogersconsulting.com/uncategorized/data-integrity-guidance/) - Data integrity is increasingly an area of focus during regulatory inspections across the GXP world and has been the subject of several guidance documents from the FDA, MHRA, and PIC/S. Review of inspectional observations suggests the industry is still struggling to meet expectations on this topic. Fortunately, the guidance are similar, which makes compliance simpler.
- [Critical Path Innovation Meetings](https://krogersconsulting.com/uncategorized/critical-path-innovation-meetings/) - I mentioned CDERs Critical Path Innovation Meeting program in a previous post on pharmacogenomics as a venue for non-regulatory meetings on a wide variety of topics. The meetings are requested by external stakeholders who wish to hold collaborative discussions about science, tools and methods that may enhance drug development. During the meeting, CDER experts would
- [Webinar on QbD](https://krogersconsulting.com/uncategorized/webinar-on-qbd/) - Sponsored by the Product Quality Research Institute (PQRI)Pharmaceutical quality practitioners may be interested in this upcoming October webinar on QbD sponsored by the Product Quality Research Institute, or PQRI. The most interesting sessions are the discussions of the QbD working group and the trends in regulatory science which will be at the start of the
- [Pharmacogenomics at the FDA](https://krogersconsulting.com/uncategorized/pharmacogenomics-at-the-fda/) - For many years now the FDA has made submission of pharmacogenomic data voluntary for most types of applications (here’s the pharmacogenomic submission guidance and its companion document, both issued in 2005). This guidance is on CDER’s update publication schedule for 2019 and is still pending notification as of this post. Some feel this type of
- [The 2019 FDA Science Forum](https://krogersconsulting.com/uncategorized/the-2019-fda-science-forum/) - Pharmaceutical and regulatory science devotees will want to catch the 2019 FDA Science Forum on September 11-12 virtually and on the FDA’s White Oak Campus in Silver Spring, MD. Participants will enjoy posters and sessions on a wide range of topics, with many presentations by FDA scientists. The sessions are concurrent, so you’ll need to
- [Updated 510k Program and Webinar in October](https://krogersconsulting.com/uncategorized/updated-510k-program-and-webinar-in-october/) - The FDA has issued several revised guidance documents this month to support the updated 510k premarket notification pathway for devices which are modified versions of already approved devices. Readers will recall the 510k review is a determination that a new device is Substantially Equivalent (SE) to an existing approved device. The updated guidances are:The Special
- [Webinar on Classifying Your Device](https://krogersconsulting.com/uncategorized/webinar-on-classifying-your-device/) - On November 5th, CDRH will host an Industry Basics Workshop on 513(g) request for information regarding the classification of a medical device. The session will be immediately followed by another on exemptions for custom devices to address unique patient or physician needs arising from physiology or pathology. The webinars are free; no registration is required.Reach
- [Is Your Automated Electronic Defibrillator (AED) FDA Approved?](https://krogersconsulting.com/uncategorized/is-your-automated-electronic-defibrillator-aed-fda-approved/) - In 2015, the FDA published a final order establishing that all Automated Electronic Defibrillators (AEDs) and their accessories require pre-market approval (PMA) based on the adverse event report and product recall history of these devices. AEDs without PMA will no longer be legal after February 3, 2021. Because these devices are critical in emergency situations,
- [Bioanalytical Methods Templates for Your NDA/BLA](https://krogersconsulting.com/uncategorized/bioanalytical-methods-templates-for-your-nda-bla/) - As we learned in the eCTD series of posts, the implementation of the standard by the FDA includes a series of technical specifications which define the format of an application and its sections. The latest technical specification, Bioanalytical Methods Templates, gives sponsors a tables format for submitting summary information on the bioanalytical methods used for
- [Happy Holidays, Everyone!](https://krogersconsulting.com/uncategorized/happy-holidays-everyone/) - I'll take a brief break from posting new material on December 24th and 26th. Please browse some earlier posts and have a happy holiday!Reach out to me if you want to know more or discuss your medical product development challenges.katrina@krogersconsulting.comlinkedin.com/in/katrinarogershttps://calendly.com/katrinarogersText Copyright © 2019 Katrina Rogers
- [New Product-Specific Guidances for Generic Drug Development](https://krogersconsulting.com/uncategorized/new-product-specific-guidances-for-generic-drug-development/) - On September 17th, the FDA published 53 product-specific draft guidances (PSGs) to facilitate generic drug development. 34 are brand new, and 16 (5 new and 11 revised) are for complex drug products, aligning with next week’s webinar on that topic. Nearly half are for products with no approved Abbreviated New Drug Application (ANDA). These PSGs
- [FDA Sponsors Innovation in Sterilization Technologies](https://krogersconsulting.com/uncategorized/fda-sponsors-innovation-in-sterilization-technologies/) - Regular readers will recall my post earlier this year on the shutdown of a Sterigenics plant in Illinois using ethylene oxide to sterilize medical devices due to repeat environmental emissions of the sterilant, which is known to cause cancer. The shutdown continues and is expanding to other facilities, causing serious shortages of certain products (read
- [I’m Excited by This Year’s Nobel Laureates in Science & Medicine](https://krogersconsulting.com/uncategorized/im-excited-by-this-years-nobel-laureates-in-science-medicine/) - The winners of the Nobel Prizes are announced in October each year, and this year’s science Prizes represent significant advances in our knowledge. I’m super excited by this year’s Nobel prize in Chemistry, given to Jennifer Doudna and Maxine Charpentier for their CRISPR work. This tool, which “allows researchers to change the DNA of animals,
- [Katrina’s Leadership Reading List for 2021](https://krogersconsulting.com/uncategorized/katrinas-leadership-reading-list-for-2021/) - 2020 has been a tough year in many ways, but we’ve also seen multiple opportunities for constructive change. Working from home and other flexible arrangements are here to stay. Widespread compliance with stay-at-home orders has shown us we can change atmospheric conditions in a short time. We will need leadership to face the challenges ahead,
- [Special Post: Life Sciences in the Northwest](https://krogersconsulting.com/uncategorized/special-post-life-sciences-in-the-northwest/) - This week we’ll be attending Life Science Innovation Northwest (LSINW), a virtual two-day meeting of investors, public and private life science organizations, research institutions, scientists, entrepreneurs devoted to the life science ecosystem in the upper left corner of the US. Seattle is a hotbed of activity, but it’s not the only place to be. Check
- [Katrina's Summer 2021 Reading List](https://krogersconsulting.com/leadership/katrinas-summer-2021-reading-list/) - Those who follow my feeds will have guessed by now that reading is my superpower (when I haven't shared that strength in person). One of my favorite summer activities was heading down to the public library for a stack of books, and I'll shout out to the Jervis Public Library for starting me on the bookworm's path.
- [What Does CLIA Mean For Laboratory Testing?](https://krogersconsulting.com/science/what-does-clia-mean-for-laboratory-testing/) - Testing for SARS-CoV-2, the virus that causes COVID-19), continues to be in the news, and you may hear the term CLIA in some of these conversations. CLIA refers to the Clinical Laboratory Improvement Amendments, which are amendments to the Public Health Act established in 1988 to establish quality standards for laboratory testing performed on human specimens for
- [Hot New Medical Technologies](https://krogersconsulting.com/science/hot-new-medical-technologies/) - Part 1 - Additive Manufacturing of Medical ProductsLately, it seems like science fiction has exploded into the media. From the rapid delivery of effective vaccines against SARS-COV-2 to the first civilians in space, the pace of change is dizzying. This month’s series will focus on four technologies that are quietly being applied in new ways
- [Innovation Cluster Fundamentals](https://krogersconsulting.com/business/innovation-cluster-fundamentals/) - Innovation clusters are a hot topic globally. Many observers are looking keenly at the efforts of the Washington State Department of Commerce to jump-start innovation clusters in that state. However, many still struggle to understand how an innovation cluster or district operates. This confusion is understandable because the cluster concept is rapidly evolving, and successes
- [Kick Start Your Company With a Business Model](https://krogersconsulting.com/leadership/kick-start-your-company-with-a-business-model/) - When I started my business, many people advised me to create a business plan. I researched business plans and quickly found them tedious to develop and cumbersome to use. Instead, I recognized I needed to understand my target customers and what would solve their problems. You can explore these fundamental questions rapidly by creating a
- [The What, How, and Why of Innovation Clusters](https://krogersconsulting.com/business/the-what-how-and-why-of-innovation-clusters/) - You may be wondering how your local companies could work with regional partners to grow, transform, or reinvent your industry to be more competitive nationally or even globally. Perhaps you’ve recently heard some the buzz about innovation clusters, or you have seen a state or federal grant program supporting cluster development. Maybe you feel your

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