Real-World Evidence: Sponsors Look To US FDA Drug Reviews For Potential Pitfalls
Methodological problems with RWE submissions for approved applications may give sponsors ‘a little bit of a pause’ as they work through data selection and analytical issues, Aetion’s Jeremy Rassen says. CDER’s Janet Woodcock says it is easier to use RWE when treatment effects are large.
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CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.
Stakeholders, some worried about "groupthink," tell the US FDA they want the individual discipline comments on newly approved drugs to stay in action packages because of the valuable insights they provide.