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U.S. Department of Health and Human Services

For Industry

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Prescription Drug User Fee Act Five-Year Plans

The Prescription Drug User Fee Act (PDUFA) provides FDA with authority to collect increasing levels of fees for the review of human drug applications. PDUFA was reauthorized and extended through fiscal year 2007 by the Prescription Drug User Fee Amendments of 2002 (PDUFA III).

In July 1998 FDA made available a PDUFA II Five-Year Plan that presented the major assumptions FDA was making and the investments it intended to make over the five-year period 1998-2002 in order to achieve the new goals associated with the Prescription Drug User Fee Act of 1992 (PDUFA), as amended and extended through the year 2002 by the Food and Drug Modernization Act of 1997. That plan was updated several times.

The first PDUFA III Five-Year Plan was published in 2003 and serves as the blueprint for FDA's planned investment of the fee revenues and appropriations expected through FY 2007. The agency may update this plan if there are any significant events that merit substantial changes.