FDA Central Review Likely For Novel Surrogate Endpoints
This article was originally published in The Pink Sheet Daily
CDER’s Woodcock says accelerated approval requirements in 21st Century Cures legislation could create a process akin to how FDA handles breakthrough designations.
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As more applications include software components, group wants assessors to apply best practices from CDRH to CDER whenever possible.
Industry official sees potential for some streamlining in user fee program, but adding to breakthrough and patient-centered activities seems most likely.
Senate Health Committee continues work on its own 21st Century Cures-related legislation, meaning the newly passed House bill will be out of the spotlight for a bit.