FDA MEETING ON GENERIC DRUG USER FEE PROGRAM

The FDA has issued notice of an upcoming public meeting on a proposed generic drug user fee program.

The FDA announced a public meeting to provide an update and gather additional stakeholder input on the development of a generic drug user fee program. The program could provide needed resources to facilitate a more timely review of generic drug applications by the FDA.

The meeting will be held on August 25, 2011 from 2:00 – 3:30pm ET at the FDA White Oak Campus, Silver Spring, MD. Stakeholders may request to give an oral presentation; time allowed for presentations will be dependent upon the number of requests received.

To register for the meeting and/or request to present at the meeting, email GDUFA_Meeting3@fda.hhs.gov.

To view the Federal Register notice of the meeting: http://www.gpo.gov/fdsys/pkg/FR-2011-07-22/html/2011-18591.htm

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