Regulations and Federal Register Documents (PDUFA)
Regulations
Federal Register Documents
- Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2021
- Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2015
- Fee for Using a Priority Review Voucher in Fiscal Year 2014
- PDUFA Patient-Focused Development: Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013-2015
- Assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License
- Applications in Prescription Drug User Fee Act V: Request for Comments
- Statement of Work for Assessment of Program
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Federal Register Notice: Public Meeting on Proposed Recommendations for PDUFA Reauthorization
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Fee for Using a Rare Pediatric Disease Priority Voucher in Fiscal Year 2016
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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 -
PDUFA Patient-Focused Drug Development: Request for Comments (posted 10/9/2014)
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Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2015 (posted 10/1/2014)
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Fee for Using a Priority Review Voucher in Fiscal Year 2014 (PDF – 211KB) (posted 9/5/2013)
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An Evaluation of the Prescription Drug User Fee Act Workload Adjuster, Request for Comments (PDF - 179KB) (posted 5/7/2013)
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PDUFA Patient-Focused Drug Development: Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013-2015 (PDF - 200KB) (posted 4/11/2013)
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Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments (PDF - 220KB) (posted 3/8/2013)
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Privacy Act of 1974; Report of a New System of Records; Food and Drug Administration User Fee System (PDF - 206KB) (posted 11/14/2012)
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PDUFA Patient-Focused Drug Development: Public Meeting and Request for Comments (PDF - 203KB) (posted 9/24/2012)
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PDUFA Patient-Focused Drug Development: Consultation Meetings; Request for Notification of Patient Stakeholder Intention to Participate (PDF - 187KB) (posted 9/24/2012)
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Fee for Using a Priority Review Voucher in Fiscal Year 2013 (PDF - 191KB) (posted 9/13/2012)
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Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form 3397 (PDF - 176KB) (posted 5/21/2012)
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Notice of Availability: Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 144KB) (posted 9/27/2011)
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Notice of Availability: Prescription Drug User Fee Act IV Information Technology Plan (PDF - 152KB) (posted 9/19/2011)
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Prescription Drug User Fee Act; Notice of Public Meeting, October 24, 2011 (PDF - 160KB) (posted 9/19/2011)
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Fee for Using a Priority Review Voucher in Fiscal Year 2012 (PDF - 153KB) (posted 8/31/2011)
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Notice of Comment Request: Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF -181KB) (posted 7/13/2011)
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Notice of Availability: Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 189KB) (posted 3/11/2011)
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Prescription Drug User Fee Act; Reopening of the Comment Period (PDF - 49KB) (posted 11/10/2010)
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Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments; November 2-3, 2010 (PDF - 109KB) (posted 10/6/2010)
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Fee for Using a Priority Review Voucher in Fiscal Year 2011 (PDF - 51KB) (posted 9/13/2010)
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Prescription Drug User Fee Act; Meetings on Reauthorization; Request for Notification of Stakeholder Intention to Participate (PDF - 51KB) (issued 6/8/2010)
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Prescription Drug User Fee Act; Notice of Public Meeting, April 12, 2010 (PDF - 52KB) (issued 3/16/2010)
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397 (PDF - 48KB) (posted 11/19/2009)
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Correction to Prescription Drug User Fee Rates for Fiscal Year 2010 (PDF - 58KB) (posted 11/13/2009)
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Pilot Program To Evaluate Proposed Proprietary Name Submissions; Procedures To Register for Participation and Submit Data or (PDF - 56KB) (posted 10/1/09)
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Notice of Availability: PDUFA IV IT Assessment (PDF - 50KB) (issued 8/21/2009)
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Public Comment on Proprietary Name Review or (PDF - 49KB) (posted 12/23/08)
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Contents of a Complete Submission for the Evaluation of Proprietary Names draft guidance or (PDF - 47KB) (Posted 11/24/08)
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PDUFA Pilot Project Proprietary Name Review Concept Paper or (PDF - 53KB) (posted 10/7/08)
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Notice of Availability: PDUFA Information Technology Plan (issued 6/30/2008)
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Notice of Availability: Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan or (PDF - 47KB) (posted May 5, 2008)
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Notice of Availability: Draft Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan (PDF - 52KB) (Posted 1/4/2008)
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Prescription Drug User Fee Act; Public Meeting, February 16, 2007 or (PDF - 95KB) (posted 1/11/2007)
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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. -
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)
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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)
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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)
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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)
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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)
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Notice of Availability: Draft Guidance for Industry and Food and Drug Administration Staff: Application User Fees for Combination Products or (PDF - 53KB).
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Statement of Work for the Evaluation of First Cycle Review Performance, Availability or (PDF - 37KB) (posted 10/21/2003)
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Prescription Drug User Fee Act (PDUFA); Public Meeting; Correction or (PDF - 33KB) (12/4/2001)
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Prescription Drug User Fee Act (PDUFA); Public Meeting Notice or (PDF - 47KB) (11/21/2001)
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Note: This notice transfers the waiver program to CDER. It also has the address where waiver requests can be submitted.