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US FDA Is Hesitant About Using Observational Studies In Real-World Evidence Framework

 
• By Sue Sutter

Agency plans guidance on whether observational studies can provide real-world evidence to support regulatory decisions about drug effectiveness; however, RWE framework includes critical questions about retrospective studies, and reflects agency concerns about transparency.

New home construction. build with wooden truss, post and beam framework.

The US FDA’s real-world evidence (RWE) framework takes a cautious approach to the use of observational studies to support new efficacy claims for approved drugs.

The agency intends to issue guidance about observational study designs using real-world data (RWD), including how such studies might provide...

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