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.

Background

• Prescription Drug User Fees -- Overview
• Prescription Drug User Fee Amendments of 2002
• PDUFA Reauthorization Performance Goals and Procedures
• Prescription Drug User Fee Act III Five-Year Plan
• PDUFA III Five Year Plan Availability - Federal Register Notice (10/14/2003)
• Letter from Tommy Thompson, Transmitting PDUFA III Performance Goals and Procedures (6/4/2002)

White Paper

• White Paper - Prescription Drug User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications