PDUFA VII: US FDA Wants Dedicated RMAT Program Funding
Cell and gene therapy product activities also have increased CBER’s workload significantly and strained staff, the agency tells industry representatives.
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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.
Other subgroups negotiating specific issues for the user fee reauthorization have indicated that agreements are close.
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.