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Home » FDA Denies Small Pharma Company’s Request for GDUFA Facility Fee Waiver
FDA Denies Small Pharma Company’s Request for GDUFA Facility Fee Waiver
The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction or postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying a citizen petition submitted by Square Pharmaceuticals.
