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.

Agreement reached — GDUFA III was the last of three FDA human drug and biologic user fee renewal agreements to be completed. • Source: Alamy

US Food and Drug Administration and industry representatives have reached an agreement to extend the generic drug user fee program another five years, which will include enhanced communications on inspections, as well as additional clarity on so-called “imminent” ANDA approvals.

FDA confirmed on 2 September that the GDUFA III talks have been completed and the ratification process among the various...