PDUFA VII Could Expand US Real-Time Review Beyond Oncology
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.
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While the prescription drug user fee agreement between industry and the US FDA is almost done, generic renewal talks remain ongoing, and biosimilar talks have not started.
Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.