US FDA details Generic Drug User Fee for APIs and finished dosage form facilities for FY2013
In a federal Register posting, the US Food and Drug Administration has announced the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year 2013.
Last July, the FDA was for the first time given the authority to collect user fees from facilities and manufacturers of generic drug products, including those making just the active ingredients for generic drugs and those just turning the active ingredients into its finished form by combining them with excipients or other additives.
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