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U.S. Department of Health and Human Services

For Industry

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PDUFA Legislation and Background

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

PDUFA must be reauthorized every five years, and was renewed in 1997 (PDUFA II), 2002 (PDUFA III), 2007 (PDUFA IV), and 2012 (PDUFA V).  PDUFA IV, reauthorized in the Food and Drug Amendments Act of 2007, was in effect through September 2012.

On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes the reauthorization of PDUFA through September 2017. PDUFA V will provide for the continued timely review of new drug and biologic license applications.  More about PDUFA V