RA/QA News Roll: Late November 2023
Here's what's happening at FDA and across the broader life science RA/QA space.
This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
If you haven’t upgraded to a paid subscription yet, you can do so here.
We’ve also added emojis to our links to denote pharma/biologic items (💊) from device/diagnostic/digital health items (💉) when there’s a clear relevance to only one sector.
Here are some key items from the past couple of weeks.
FDA Guidances and Related Documents
The FDA has released new guidance documents regarding the notification process for permanent or temporary interruptions in device manufacturing that may lead to shortages. Additionally, the FDA has announced an upcoming meeting scheduled for February 2024 to discuss the 506J Device List, which is related to this topic. 💉
The FDA has recently issued a new final rule that sets forth fresh requirements for direct-to-consumer drug advertising. In summary, the rule mandates that direct-to-consumer drug ads should not include any distracting elements while presenting the "major statement" about drug effects and contraindications. This includes avoiding audio or visual distractions. Notably, the rule was in development for over a decade, despite Congress initially calling for its finalization within 30 months after the passage of the FDA Amendments Act in 2007.
The FDA's CBER has recently published an updated Standard Operating Policy and Procedure (SOPP) regarding regulatory meetings with sponsors and applicants for drugs and biological products. The document, revised on November 22, includes a new appendix that addresses "considerations on the type of meeting granted and issuance of Written Response Only (WRO)." It also incorporates "general updates" to the SOPP.
Janet Woodcock, who serves as the FDA's Principal Deputy Commissioner, is scheduled to retire from the agency in early the next year. FDA Commissioner Robert Califf announced that Namandjé Bumpus will succeed her. Bumpus, who currently serves as the FDA's Chief Scientist, is a highly accomplished scientist and expert in pharmacology. She joined the agency in June 2022 and is now tasked with overseeing significant changes, such as the revamp of the Office of Regulatory Affairs and the human foods program. However, it remains to be seen whether her relatively short tenure will be an advantage or a hindrance in implementing these changes.