CBER Proposes Increasing Cell, Gene Therapy Staff In PDUFA VII
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.
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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.
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.
Acting CDER Director Cavazzoni says it is ‘a very active time’ as many clinical trials for COVID-19-related products are expected to read out soon.