PDUFA Renewal Negotiations Nearly Complete, With CBER Slated For Major Resource Increase
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.
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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 GDUFA III negotiations continue, FDA doesn’t seem ready to make additional changes to approval process, but industry argues guidance practices and communications need fixing and that consumers are missing out on potential savings because of it.
Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.