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  1. Prescription Drug User Fee Amendments

FDA periodically conducts meetings on the Prescription Drug User Fee Act (PDUFA) program. The current legislative authority for PDUFA (PDUFA V), reauthorized in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA), will expire in September 2017. The Federal Food, Drug, and Cosmetic Act (FD&C Act) 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 (FY2018-2022).  More information on the upcoming reauthorization effort can be found here:  PDUFA VI

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

PDUFA V Public Meetings

PDUFA IV Public Meetings

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