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U.S. Department of Health and Human Services

For Industry

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PDUFA Meetings

FDA periodically conducts meetings on the Prescription Drug User Fee Act (PDUFA) program. The current legislative authority for PDUFA (PDUFA IV), reauthorized in 2007 by the FDA Amendments Act (FDAAA), will expire in September 2012.  FDAAA requires that FDA hold public meetings and conduct discussions with both the regulated industry and stakeholder groups in developing recommendations for the next PDUFA program (FY2013-2017). 

This page contains information for both the public part of the PDUFA reauthorization process and the discussions FDA holds with industry and stakeholders.  


PDUFA Public Meeting October 24, 2011

The October 24, 2011 meeting was held to discuss the proposed recommendations for the reauthorization of PDUFA.


PDUFA IV Public Meetings

Information about the three major public meetings that were held for PDUFA IV