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Home » FDA Denies Square Pharmaceuticals’ Petition to Revise GDUFA Facility Fees
FDA Denies Square Pharmaceuticals’ Petition to Revise GDUFA Facility Fees
The Generic Drug User Fee Amendments of 2012 do not allow for a waiver, reduction nor postponement of finished dosage form (FDF) facility fees for small and/or foreign businesses, the FDA says in a letter denying Square Pharmaceuticals’ citizen petition requesting a waiver and change to GDUFA’s statutory language.