Prescription Drug User Fee Act (PDUFA) Guidances / Rules
The documents on this page are arranged in order by date, with the most recent document added to the top of the list.
FEDERAL REGISTER: Pilot Program To Evaluate Proposed Name Submissions; Concept Paper; Notice - 10/7/2008
- PDUFA Pilot Project Proprietary Name Review; Concept Paper (PDF -295 KB) - 9/2008
Guidance for Industry and FDA Staff: Application User Fees for Combination Products - 4/20/2005 - (PDF), (Text)
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 - (PDF), (Text)
Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products - 3/30/2005
Guidance for Industry: Premarketing Risk Assessment - 3/25/2005
Guidance for Industry: Development and Use of Risk Minimization Action Plans - 3/25/2005
Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment - 3/25/2005
Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees - 1/3/2005 - (PDF), (Text)
Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols - 8/18/2004 - (PDF), (Text)
Guidance for Industry: Continuous Marketing Applications: Pilot 1 - Reviewable Units for Fast Track Products Under PDUFA - 10/6/2003 - (PDF), (Text)
Guidance for Industry: Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA - 10/6/2003 - (PDF), (Text)
Guidance for Industry: Special Protocol Assessment - 5/16/2002 - (PDF), (Text)
Guidance for Industry Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act - 11/21/2001 - (PDF), (Text)
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds - 10/26/2000 - (PDF), (Text)
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products - 3/7/2000 - (PDF), (Text)
Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level - 3/7/2000 - (PDF), (Text)