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Public Meeting on GDUFA Reauthorization

04/21/2015

Federal Register Notice: FDA will hold a public meeting 6/15 on the Generic Drug User Fee Amendments (GDUFA) of 2012. The FD&C Act requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization which expires 9/2017 it publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the Generic Drug User Fee Act Program Performance Goals and Procedures. The meeting will be held from 9 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact Connie Wisner, (240) 402-7946, Connie.Wisner@fda.hhs.gov; or Kimberly Giordano, 301-796-1071, Kimberly.Giordano@fda.hhs.gov. To view this notice, click here.

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