Guidance Documents

• Attachment D - Application, Product, and Establishment Fees: Common Issues and Their Resolution, Revised December 16, 1994

• Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees [PDF] (2/21/2001)
  

• Attachment F - Interim Guidance on Applicability of User Fees to (1) Applications Withdrawn Before Filing, or (2) Applications the Agency Has Refused to File and That Are Resubmitted or Filed Over Protest, July 12, 1993

• Attachment G - Draft Interim Guidance Document for Waivers of and Reductions in User Fees, July 16, 1993 (Posted 5/13/99)

• Classifying Resubmissions in Response to Action Letters, May 14, 1998

• Continuous Marketing Application (CMA) Pilot Programs (Posted 3/9/2004)

• Fees-Exceed-The-Costs Waivers Under the Prescription Drug User Fee Act, June 1999 (Posted 8/25/99)   (addendum FY 2003 standard costs chart).  (Posted 5/10/2004)

• Draft Guidance for Industry and FDA Staff: Application User Fees for Combination Products. Federal Register notice [TXT] [PDF]  (9/29/2004)

• Formal Meetings With Sponsors and Applicants for PDUFA Products [HTML] or [PDF] (Issued 2/2000, Posted 3/6/2000)

• Submitting and Reviewing Complete Responses to Clinical Holds, May 14, 1998 [HTML] or [PDF]

Legislation

• Federal Food, Drug, and Cosmetic Act, Sections 735 and 736

• PDUFA III 

Letters

• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, 5/5/2004 [HTML] or [PDF]
  PDF Attachments: Attachment A  Attachment B (Posted 5/13/2004)

• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, 5/5/2003 [HTML] or [PDF] (Posted 5/9/2003)

• The Prescription Drug User Fee Act (PDUFA) Dear Colleague letter, 6/12/2002 [HTML] or [PDF] (Posted 5/9/2003)

• Text of the June 4, 2002, letter transmitting the PDUFA III performance goals and procedures (10/2003)

• PDUFA III Reauthorization Performance Goals and Procedures (Enclosure from 6/4/2002 letter) (10/2003)

• The Prescription Drug User Fee Act (PDUFA) User Fee Correspondence, 10/1/97 [HTML] or [PDF]

• 11/12/97 Sec. Shalala letter to Sen. Jeffords regarding the goals pertaining to the reauthorization of the Prescription Drug User Fee Act

• PDUFA Reauthorization Performance Goals and Procedures (Enclosure from 11/12/97 Sec. Shalala letter to Sen. Jeffords)

MaPPs

• MAPP 6020.4, Classifying Resubmissions of Original NDAs in Response to Action Letters, Issued 5/1/1998

• MAPP 6050.1, Refusal to Accept Application for Filing From Applicants in Arrears, Issued 11/1/95

Other

• Important notice - pediatric supplements no longer exempt from fees (1/8/2002)

• Payment Instructions for Applications and Supplements (updated 3/15/2004)

• PDUFA 3 Five Year Plan (10/2003)

• User Fee Cover Sheet, Form FDA 3397, revised 1/2003 [PDF] or [WORD] (Posted 5/29/2003)

• Electronic Regulatory Submission and Review (ERSR) Program--PDUFA II Information Management Advisory Board

• Electronic Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)

Reports

Performance

• Prescription Drug User Fee Act (PDUFA) FY 2003 Performance Report to Congress  (5/2004)
   

• Prescription Drug User Fee Act (PDUFA) FY 2002 Performance Report to Congress  (10/2003)
  
  

• Prescription Drug User Fee Act (PDUFA) FY 2001 Performance Report to Congress  (1/2002)
  
  

• Prescription Drug User Fee Act (PDUFA) FY 2000 Performance Report to Congress  (3/19/2001)
  
  

• Prescription Drug User Fee Act (PDUFA) FY 1999 Performance Report to Congress [HTML] or [PDF]
  
  

• Prescription Drug User Fee Act (PDUFA) FY 1998 Performance Report to Congress [HTML] or [PDF]

• Prescription Drug User Fee Act (PDUFA) FY 1997 Performance Report to Congress (HTML)

• Prescription Drug User Fee Act (PDUFA) FY 1996 Performance Report to Congress (HTML)

• Prescription Drug User Fee Act (PDUFA) FY 1995 Performance Report to Congress (HTML)

Financial

• Prescription Drug User Fee Act (PDUFA) FY 2003 Financial Report to Congress [HTML] [PDF] (05/2004)
• Prescription Drug User Fee Act (PDUFA) FY 2002 Financial Report to Congress [HTML] [PDF] (10/2003)

• Prescription Drug User Fee Act (PDUFA) FY 2001 Financial Report to Congress (2/2002)

• Prescription Drug User Fee Act (PDUFA) FY 2000 Financial Report to Congress (1/26/2001)

• Prescription Drug User Fee Act (PDUFA) FY 1999 Financial Report to Congress (3/14/2000)

• Prescription Drug User Fee Act (PDUFA) FY 1998 Financial Report to Congress [HTML] or [PDF]

• Prescription Drug User Fee Act (PDUFA) FY 1997 Financial Report to Congress

• Prescription Drug User Fee Act (PDUFA) FY 1995 Financial Report to Congress

FDA/Center for Drug Evaluation and Research
Last Updated: September 28, 2004
Originator: CDER
HTML by MJ, SJW