Prescription Drug User Fee Act (PDUFA)

FDA PDUFA Information

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Billable Products

• User Fee Billable Products Approved Under Section 351 of the PHS Act
• PDUFA Guidances / Rules

Forms

• PDUFA User Fee Cover Sheet
• 2005 Dear Colleague Letter

Performance Reports

• FY 2003 Performance Report to Congress
• FY 2002 Performance Report to Congress
• FY 2001 Performance Report to Congress
• FY 2000 Performance Report to Congress
• FY 1999 Performance Report to Congress
• FY 1998 Performance Report to Congress - (PDF)
• FY 1997 Performance Report to Congress
• FY 1996 Performance Report to Congress
• FY 1995 Performance Report to Congress

PDUFA III

• PDUFA III Five-Year Plan - July, 2003
  • FEDERAL REGISTER Prescription Drug User Fee Act III Five-Year Plan; Availability - 10/14/2003 - (PDF)
• PDUFA Reauthorization Performance Goals and Procedures
• Prescription Drug User Fee Amendments of 2002
• PDUFA III Letter - Tommy Thompson - 6/4/2002

PDUFA II

• PDUFA II Meeting 2000: Consulting with Stakeholders - 9/15/2000
• PDUFA II Five-Year Plan - July, 1998
• PDUFA II Five-Year Plan - FY 1999 Revision - July 1999 - Describes plans to achieve the new goals associated the 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.
• PDUFA II Five-Year Plan - FY 2000 Update - July 2000 - Provides background information on PDUFA and a summary of the PDUFA II goals, and discusses the 10 major assumptions on which the plan is based and how those assumptions have changed since the original plan was issued in 1998.
• PDUFA II Letter - Donna Shalala - 11/12/1997
• PDUFA II Reauthorization Performance Goals and Procedures - 11/12/1997 - (PDF)

User Fee Information

• FEDERAL REGISTER: Notice to Industry on the Development of a Web-Based System for Obtaining a User Fee Payment Identification Number and Prescription Drug User Fee Cover Sheet (FDA Form 3397) - 3/9/2005 - (PDF)
• FEDERAL REGISTER Establishment of Prescription Drug User Fee Rates
  • Fiscal Year 2008 - 10/12/2007 - (PDF - 123 KB))
  • Fiscal Year 2007 - 8/2/2006 - (PDF)
  • Fiscal Year 2005 - 8/2/2004 - (PDF)
  • Fiscal Year 2004 - 8/1/2003 - (PDF)
  • Fiscal Year 2003 - 8/2/2002 - (PDF)
  • Fiscal Year 2002 - 1/16/2002 - (PDF)
  • Fiscal Year 2001 - 12/18/2000 - (PDF)
  • Fiscal Year 2000 - 12/28/1999 - (PDF)
  • Fiscal Year 1999 - 12/22/1998 - (PDF)
  • Fiscal Year 1998 - 12/9/1997 - (PDF)

CBER Information

Useful Government Sites