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...
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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...
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...
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...
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,...
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...
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...
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...