On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA). This new law includes the reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.

FDA developed the proposed enhancements for PDUFA VI in consultation with drug industry representatives, patient and consumer advocates, health care professionals, and other public stakeholders from September 2015 through February 2016. FDA transmitted these proposed enhancements to Congress in December 2016, which are referred to in Title I of FDARA.

The new law ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2018-2022 that will allow the agency to fulfill its mission to protect and promote public health by helping to bring to market critical new medicines for patients. This page contains the relevant information related to PDUFA VI and FDA’s implementation of the PDUFA VI enhancements.

Implementation

• Completed PDUFA VI Deliverables
• Financial Transparency and Efficiency
• Resource Capacity Planning and Modernized Time Reporting
• Food and Drug Administration Reauthorization Act (FDARA) of 2017 Hiring Data
• Assessment of FDA-Sponsor Communication Practices During the IND Stage of Drug/Biologic Development (PDF)

PDUFA Public Meeting August 15, 2016

• PDUFA VI Commitment Letter
• Federal Register Notice: Public Meeting on Proposed Recommendations for PDUFA Reauthorization
• Meeting Agenda
• Meeting Slides
• Meeting Recording Part 1
• Meeting Recording Part 2
• Meeting Recording Part 3
• Meeting Transcript
• PDUFA VI Docket Comment Summary

Stakeholder Discussions on PDUFA VI Reauthorization

• September 28, 2015
• October 29, 2015
• November 16, 2015
• December 17, 2015
• January 15, 2016
• February 19, 2016

Industry Discussions on PDUFA Reauthorization

• September 16, 2015 Steering Committee
• September 29, 2015 Pre-Market Subgroup
• September 29, 2015 Steering Committee
• September 29 and 30, 2015 Financial Subgroup
• October 6, 2015 Pre-Market Subgroup
• October 6, 2015 Steering Committee
• October 7, 2015 Pre-Market Subgroup
• October 7, 2015 Regulatory Decision Tools Subgroup
• October 7, 2015 Post-Market Subgroup
• October 7, 2015 Finance Subgroup
• October 7, 2015 IT Subgroup
• October 13, 2015 Steering Committee
• October 14, 2015 Pre-Market Subgroup
• October 14, 2015 Regulatory Decision Tools Subgroup
• October 14, 2014 Post-Market Subgroup
• October 14, 2015 Finance Subgroup
• October 14, 2015 IT Subgroup
• October 20, 2015 Steering Committee
• October 21, 2015 Pre-Market Subgroup
• October 21, 2015 Regulatory Decision Tools Subgroup
• October 21, 2015 Finance Subgroup
• October 21, 2015 Postmarket Subgroup
• October 21, 2015 IT Subgroup
• October 28, 2015 Finance Subgroup
• November 3, 2015 Pre-Market Subgroup
• November 3, 2015 Steering Committee
• November 4, 2015 Regulatory Decision Tools Subgroup
• November 4, 2015 Finance Subgroup
• November 4, 2015 IT Subgroup
• November 4, 2015 Postmarket Subgroup
• November 10, 2015 Steering Committee
• November 17, 2015 Steering Committee
• November 18, 2015 Pre-Market Subgroup
• November 18, 2015 Finance Subgroup
• November 18, 2015 Regulatory Decision Tools Subgroup
• November 18, 2015 Postmarket Subgroup
• November 18, 2015 IT Subgroup
• December 1, 2015 Steering Committee
• December 2, 2015 Pre-Market Subgroup
• December 2, 2015 Regulatory Decision Tools Subgroup
• December 2, 2015 Post-Market Subgroup
• December 2, 2015 Finance Subgroup
• December 2, 2015 IT Subgroup
• December 8, 2015 Pre-Market Subgroup
• December 9, 2015 Post-Market Subgroup
• December 15, 2015 Pre-Market Subgroup
• December 15, 2015 Regulatory Decision Tools Subgroup
• December 15, 2015 Post-Market Subgroup
• December 15, 2015 Finance Subgroup
• December 15, 2015 IT Subgroup
• December 16, 2015 Pre-Market Subgroup
• December 16, 2015 Steering Committee
• January 12, 2016 Pre-Market Subgroup
• January 12, 2016 Regulatory Decision Tools Subgroup
• January 12, 2016 Post-Market Subgroup
• January 12, 2016 Finance Subgroup
• January 12, 2016 IT Subgroup
• January 13, 2016 Pre-Market Subgroup
• January 13, 2015 Steering Committee
• January 19, 2016 Pre-Market Subgroup
• January 19, 2016 Regulatory Decision Tools Subgroup
• January 19, 2016 Post-Market Subgroup
• January 19, 2016 Finance Subgroup
• January 19, 2016 IT Subgroup
• January 20, 2015 Steering Committee
• January 26, 2016 Pre-Market Subgroup
• January 26, 2016 Post-Market Subgroup
• January 27, 2016 Steering Committee
• January 27 and 28, 2016 Financial Subgroup
• January 29, 2016 Steering Committee

PDUFA Public Meeting July 15, 2015

• Meeting Transcript, July 15, 2015
• Federal Register Notice announcing July 15, 2015 Public Meeting
• Registration for Public Meeting on PDUFA VI
• Webcast Recording Part 1
• Webcast Recording Part 2
• Webcast Recording Part 3
• Meeting Agenda
• Public Docket
• FDA Presentation Slides: PDUFA Background and Reauthorization Process, July 2015