Prescription Drug User Fee Act
Reports and Plans

The Prescription Drug User Fee Act (PDUFA) provides FDA with increasing levels of resources for the review of human drug applications. Fees that FDA collected from drug and biologics firms from 1993 to 2002 were used to reduce the time required to evaluate certain human drug applications without compromising review quality. FDA has submitted annual Performance and Financial Reports to Congress on progress in streamlining the drug review process and use of PDUFA fees. PDUFA has been amended and extended through Sept. 30, 2007. The amended act is now referred to as PDUFA III and its predecessors as PDUFA I and PDUFA II.

PDUFA Performance Reports

• FY 2002 Performance Report to Congress New!
• FY 2001 Performance Report to Congress
  • PDF version of Report (4.55 MB)
  • PDF version of Appendices (675 KB)
• FY 2000 Performance Report to Congress
• FY 1999 Performance Report to Congress
• FY 1998 Performance Report to Congress
• FY 1997 Performance Report to Congress
• FY 1996 Performance Report to Congress
• FY 1995 Performance Report to Congress

PDUFA Financial Reports

• FY 2002 Financial Report to Congress (PDF 105 KB)
• FY 2001 Financial Report to Congress
• FY 2000 Financial Report to Congress
• FY 1999 Financial Report to Congress (1.30 MB)
• FY 1998 Financial Report to Congress
• FY 1997 Financial Report to Congress (938 KB)
• FY 1995 Financial Report to Congress (1.10 MB)

PDUFA Five-Year Plan

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