Wednesday, September 29, 2021

Very Brief Blog; FDA Releases New Guidance for Risk/Benefit and for Real World Evidence

Endpoint news has an article noting that FDA just released 5 new guidance documents.  

Two are of major interest.   The first is a 23 page draft guidance on how FDA will frame its approach to risk/benefit assessments for drugs and biologicals.  Here.    The second is a 39 page draft guidance on how FDA will assess real world evidence, particularly, EHR data and payor medical claims data.  Here.

Both will have Federal Register announcements that give a specific 60-day time frame for comments and a comment channel (portal).   They'll come out September 30.   Risk Benefit here.  RWE here

Risk-benefit frameworks, of course, are also relevant to FDA approval of medical devices and diagnostics, and have analogies to medical benefit (risk/benefit) decisions at payors.

The risk benefit can be summed up in a short table (in an almost comically simple and short table...), although the point of the 23-page document is providing background to what this table really means.