GDUFA III Talks Completed; Fees will Fund Inspection, Complex Generic Improvements
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.
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In FY '21 third quarter, on-time decision rate improved for generics and biosimilars, but dropped again for new drug applications.
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.
Final commitment letter preparations now under way as revenue issues are resolved.