FDA HOLDS PUBLIC MEETING ON GENERIC DRUG USER FEE PROGRAM

On Tuesday, May 10, 2011, the FDA hosted a public meeting to gather stakeholder input regarding a proposed generic drug user fee program. A user fee program could provide necessary supplemental funding, in addition to current Congressional appropriations, to facilitate the timely review of human generic drug applications by FDA, and FDA is currently in negotiations with the regulated industry aimed at providing a consensus proposal for congressional consideration.

FDA has reopened the docket at Regulations.gov through which stakeholders can provide comment. The docket number is FDA-2010-N-0381.

To view a summary of the meeting: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM255187.pdf

To view the slide presentation from the meeting: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM255189.pdf

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