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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A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.
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.