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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
Today the U.S. Food and Drug Administration (FDA) published the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA). This announcement includes the rate for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), drug master file (DMF), active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees.
GDUFA authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on certain generic FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference for generic applications.
These fees are effective on October 1, 2014, and will remain in effect through September 30, 2015.
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