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U.S. Department of Health and Human Services

For Industry

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Generic Drug User Fee (GDUF) Public Meeting: August 25, 2011

The Food and Drug Administration (FDA) held a public meeting to provide a public update and to gather additional stakeholder input on the development of a 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.  FDA has been in negotiations with the regulated industry aimed at providing a consensus proposal for Congressional consideration.  In the interest of transparency, and to assure that all interested stakeholders views are heard and considered FDA held it’s fourth public meeting on this topic to provide an update and to gather additional input on such a program.