FDA Seeks Comments, Will Hold Public Hearing On GDUFA Policy

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FDA announced a public hearing to solicit public comment on certain topics relating to implementation of the Generic Drug User Fee Amendments of 2012.

United States Food, Drugs, Healthcare, Life Sciences

In the August 19, 2014, Federal Register, FDA requested comments and announced a public hearing to solicit public comment on certain topics relating to implementation of the Generic Drug User Fee Amendments of 2012 ("GDUFA") and the GDUFA Commitment Letter that accompanies the legislation. FDA is seeking participation at the public hearing and written comments from all interested parties. The hearing will be held on September 17, 2014, in Hyattsville, MD. Comments will be accepted after the hearing until October 13, 2014.

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