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Public Meeting on Generic Drug User Fee Act

12/08/2011

Federal Register Notice: FDA will hold a public meeting 12/19 to discuss proposed recommendations for enacting a Generic Drug User Fee Act, which will authorize the agency to collect fees and use them for processing the review of human generic drug applications, associated Type II Active Pharmaceutical Ingredient Drug Master Files, and for conducting associated inspections for fiscal years 2013–2017. New legislation would be required and FDA and industry have developed a proposal for Congressional consideration. FDA is also publishing the negotiated recommendations (the goals letter). The meeting will be held from 10 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 2, Rm. 2047, Silver Spring, MD. The meeting will also be Web cast. Contact Mari Long, (301) 796–7574. To view this notice, click here.

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