PDUFA Legislation and Background: PDUFA III
Recognizing the necessity of reauthorizing PDUFA before the end of FY 2002 to assure continuity of operations, Congress enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This Act included the Prescription Drug User Fee Amendments of 2002 (PDUFA III), reauthorizing user fees through FY 2007. The President signed PDUFA III into law on June 12, 2002.
Prescription Drug User Fees -- Overview Prescription Drug User Fee Amendments of 2002 PDUFA Reauthorization Performance Goals and Procedures Prescription Drug User Fee Act Five-Year Plans
- PDUFA III Five Year Plan Availability - Federal Register Notice (10/14/2003) (PDF - 35KB)
- Letter from Tommy Thompson, Transmitting PDUFA III Performance Goals and Procedures (6/4/2002)