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Background - PDUFA III

Table of Contents: PDUFA III Five-Year Plan

Previous Section : Background: PDUFA II

Because of the continued success of this program, PDUFA was again reauthorized for another five years. That reauthorization was contained in the Prescription Drug User Fee Amendments of 2002 (Title 5 of the Public Health and Security and Bioterrorism Preparedness and Response Act of 2002), signed by the President on June 12, 2002. This reauthorization covers fiscal years 2003 through 2007, and is known as PDUFA III.

PDUFA III corrects some of the flaws in PDUFA II and should provide for more stable fee revenues over the next five years. It should provide sufficient resources for FDA to continue to be able to meet the challenging PDUFA III goals and undertake pilot programs and new initiatives. Fee revenues should be sufficient to sustain the 1,088 staff years supported by fees in FY 2002, and to add at least an additional 376 staff years. PDUFA III also permits fee revenues to be used for some post-approval risk management activities for the first time. The goals for PDUFA III were set forth in letters from the Secretary of Health and Human Services to Congressional Committee Chairmen on June 4, 2002.

Next Section : Background - PDUFA Goals