Note: I used the AI Assist Drafting in Notion to generate some topics and content blocks. Photo by National Cancer Institute on Unsplash Introduction The FDA issued final guidance on the qualification process for Drug Development Tools (DDTS) in November 2020 after...
Medical Products
The 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...
The FDA’s Approach to DHT is Evolving
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...
What is Pharmaceutical Advanced Manufacturing?
Pharmaceutical manufacturing has traditionally been a batch-based process, with different stages of production being conducted in discrete steps. However, in recent years there has been an increasing interest in continuous manufacturing as an alternative to...
Turnaround Time and Success Rate for Medical Device Decisions
All medical device companies need to include a success rate and time to decision for their submissions in their go-to-market plan. It turns out that helpful information on both subjects is readily available from the FDA.
Customer and Product Discovery Through Data
Photo by Tool., Inc on Unsplash 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 –...
Resolving the Biomanufacturing Talent Shortage
I’ve been working on talent development projects since 2018. Still, this effort kicked into a higher gear in 2020 when we received a grant to develop a Bioscience Career Launch program in our regional high schools. I’ve learned much from my colleagues and...
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. The number of commercially available mobile devices incorporating biosensors has increased dramatically since the first smartphone in 2007. The...