For Industry

PDUFA VI: Fiscal Years 2018 - 2022

The current legislative authority for PDUFA expires in September 2017. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the human drug review process.

This website will be updated as further information on the PDUFA Reauthorization process becomes available.

Stakeholder Discussions on PDUFA VI Reauthorization

Industry Discussions on PDUFA Reauthorization

The minutes of meetings between FDA and the regulated industry are posted below.

Page Last Updated: 12/22/2016
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