FDA Denies Square Pharmaceuticals’ Petition to Revise GDUFA Facility Fees

Drug Industry Daily
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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.

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