Regulations and Federal Register Documents (PDUFA)

Regulations

• Complete Response Letter Final Rule

Federal Register Documents  

• Establishment of Prescription Drug User Fee Rates for Fiscal Years 1998 - present  
  List of Federal Register notices that announce the drug user fee rates for each fiscal year   
• Prescription Drug User Fee Rates for Fiscal Year 2010; Correction (PDF - 58KB) (Posted 11/13/2009)
• Pilot Program To Evaluate Proposed Proprietary Name Submissions; Procedures To Register for Participation and Submit Data or (PDF - 56KB) (Posted 10/1/09)
• Federal Register Notice: PDUFA IV IT Assessment (PDF -  50KB) (8/21/2009) 
  • PDUFA IV IT Assessment (PDF - 306KB)
• Public Comment on Proprietary Name Review or (PDF - 49KB) (Posted 12/23/08)
• Contents of a Complete Submission for the Evaluation of Proprietary Names draft guidance or (PDF - 47KB) (Posted 11/24/08)
  • Draft Guidance (PDF - 255KB)
• PDUFA Pilot Project Proprietary Name Review Concept Paper or (PDF - 53KB) (Posted 10/7/08)
• Concept Paper (PDF - 295KB)
• Federal Register Notice: PDUFA Information Technology Plan (6/30/2008)
  • PDUFA IV Information Technology Plan (PDF - 696KB)
• Notice of Availability: Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan or (PDF - 47KB) (Posted May 5, 2008)
• Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Draft) (PDF - 114KB) (4/1/2008)
• Draft Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan Federal Register Notice (PDF - 52KB) (Posted 1/4/2008)
  • Draft PDUFA IV Information Technology Plan (PDF - 2170KB)
• Prescription Drug User Fee Act; Public Meeting, February 16, 2007 or (PDF - 95KB) (Posted 1/11/2007)
• FDA News Release
• Fact Sheet
• Meeting agenda
• Meeting presentations
• Prescription Drug User Fee Act; Public Meeting or (PDF - 62KB) (10/18/2005)
  On November 14, 2005, FDA held a public meeting on PDUFA and at the same time opened a public docket (2005N-0410) where people can submit written comments.
•  More information on the public meeting
•  FDA News Release 
• Notice of Availability: Guidance for Industry and Food and Drug Administration Staff: Application User Fees for Combination Products or (PDF - 50KB).  The Final Guidance (5/3/2005) 
• Notice of Availability: Draft Guidance for Industry on User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR or (PDF - 50KB).  The Draft Guidance (PDF - 46KB) (Posted 4/19/2005) 
• Notice of Availability: Guidance for Industry on Good Review Management Principles for PDUFA Product or (PDF - 52KB).  The Final Guidance (PDF - 683KB) (Posted 4/11/2005) 
• 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); Availability or (PDF - 47KB) (3/10/2005) 
• Notice of Availability: Guidance for Industry on Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees or (PDF - 50KB).  The Final Guidance (PDF - 212KB) (1/3/2005) 
• Notice of Availability: Draft Guidance for Industry and Food and Drug Administration Staff: Application User Fees for Combination Products or (PDF - 53KB).  The Draft Guidance (PDF - 1MB) (9/29/2004) 
•  Statement of Work for the Evaluation of First Cycle Review Performance, Availability or (PDF - 37KB) (Posted 10/21/2003) 
  • Sample Statement of Work for the Evaluation of First Cycle Review Performance (PDF - 88KB) (10/21/2003)
• Prescription Drug User Fee Act (PDUFA); Public Meeting; Correction or (PDF - 33KB) (12/4/2001)
• Prescription Drug User Fee Act (PDUFA); Public Meeting Notice or (PDF - 47KB) (11/21/2001)
• Delegations of Authority and Organization; Office of the Commissioner and the Center for Drug Evaluation and Research (64 FR 59617, November 3, 1999) (PDF - 20KB) (11/19/1999)

Note: This notice transfers the waiver program to CDER. It also has the address where waiver requests can be submitted.