Amgen, Regeneron and others seek more detail from FDA on real-world data plans
Back in late September, the FDA released a long-awaited guidance on how the industry might use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety.
The draft guidance offered some light from FDA on which strategies might help a sponsor get a new approval across the finish line or help with an sNDA or sBLA. A total of 57 comments were filed on the draft, with some companies like Regeneron, Janssen, and Amgen, as well as industry groups like PhRMA and the RWE Alliance, seeking additional clarity and offering suggestions.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.