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FDA - Real-World Evidence Program

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Figured this might be of interest to folks here:

 

https://www.fda.gov/media/120060/download

 

"Section 505F(b) of the FD&C Act defines RWE as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials” (21 U.S.C. 355g(b)).5 In developing its RWE program, FDA believes it is helpful to distinguish between the sources of RWD and the evidence derived from that data. Evaluating RWE in the context of regulatory decision-making depends not only on the evaluation of the methodologies used to generate the evidence but also on the reliability and relevance of the underlying RWD; these constructs may raise different types of considerations."

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This is interesting. The FDA "grandfathered" in a bunch of drugs that had been in common use before the adoption of efficacy standards in 1962 but in 2006 started to demand clinical trials for some of these drugs to remain on the market...I wonder if this is a partial reversal of that position.

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