Guidance Documents and MaPPs (PDUFA)

MaPPs (Manual of Policies and Procedures)

• MAPP 6020.4, Classifying Resubmissions of Original NDAs in Response to Action Letters (PDF - 26KB), Issued 5/1/1998

• MAPP 6050.1R, Refusal to Accept Application for Filing From Applicants in Arrears (PDF - 29KB), Issued 8/14/2007

Guidance Documents

• Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 287KB) [Federal Register Notice (PDF - 144KB)] (9/27/2011)  Please note that there has been a change in the address for submission of waivers, refunds, and reductions (see pages 16-18 of the Guidance). The new room number is 6288. (3/2/2012)

• Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names draft guidance (PDF - 255KB) (11/24/08)    

• Attachment D - Application, Product, and Establishment Fees: Common Issues and Their Resolution, Revised December 16, 1994 (PDF - 357KB) 

• Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (PDF - 212KB) (1/3/2005) 
• Attachment F - Interim Guidance on Applicability of User Fees to (1) Applications Withdrawn Before Filing, or (2) Applications the Agency Has Refused to File and That Are Resubmitted or Filed Over Protest, July 12, 1993 (PDF - 106KB) 
• Guidance for Industry: User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR Final Guidance (PDF - 46KB) (posted 2/7/2007)
• Draft Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan or (PDF - 52KB) (posted 1/4/2008)
  • The Draft Plan (PDF - 2MB) 
• Classifying Resubmissions in Response to Action Letters, May 14, 1998 (PDF- 76KB) 
• Continuous Marketing Application (CMA) Pilot Programs (posted 3/9/2004) 
• Fees-Exceed-The-Costs Waivers Under the Prescription Drug User Fee Act, June 1999 (PDF - 48KB) (posted 8/25/99) 
  (Addendum FY 2011 Standard Costs chart) or (PDF - 14KB) (updated 9/13/2012)
• Guidance for Industry and FDA Staff: Application User Fees for Combination Products.  [Federal Register Notice or (PDF - 50KB)] (5/3/2005)
• Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 31KB) (issued 2/2000, posted 3/6/2000)
• Good Review Management Principles for PDUFA Products (PDF - 683KB) (posted 4/11/2005) 
• Submitting and Reviewing Complete Responses to Clinical Holds, May 14, 1998 (PDF - 26KB)
• Guidance for Industry and FDA Staff: Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product (4/11/2005)
• Guidance for Industry: Premarketing Risk Assessment (PDF - 91KB) (3/25/2005)
• Guidance for Industry: Development and Use of Risk Minimization Action Plans (PDF - 84KB) (3/25/2005)
• Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (PDF - 220KB) (3/25/2005)
• Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols (8/18/2004)
• Guidance for Industry: Special Protocol Assessment (PDF - 36KB) (5/16/2002)  
• Guidance for Industry Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (PDF - 27KB) (11/21/2001)
• Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30KB) (3/7/2000)