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FDA Posts Generic Drug User Fee Rates


Federal Register Notice: FDA is announcing the rates for ANDAs ($70,480), prior approval supplements to an approved ANDA ($35,240), drug master files ($51,140), generic drug active pharmaceutical ingredient facilities ($44,234), foreign API facility ($59,234), and finished dosage form facilities ($258,646) and foreign finished dosage form facility ($273,646) user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2017. These fees are effective 10/1 and will remain in effect through 9/30/17. To view this notice, click here.