SPECIALTY RX FACTS

18Jan/120

FDA Submits Generic, Brand Drug User Fee Bill Language to Congress

FDA Submits Generic, Brand Drug User Fee Bill Language to Congress

Generic drugmakers won’t have long to wait after Congress passes a user fee bill to learn the various fee levels in the Generic Drug User Fee Act (GDUFA).  Under statutory language delivered to Capitol Hill on Friday, the FDA would
have only until Oct. 31 to establish fee levels for a one-time backlog fee, a drug master file fee and various application and supplement fees.

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