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  1. Prescription Drug User Fee Amendments

PDUFA VI: Fiscal Years 2018 - 2022

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

PDUFA Public Meeting August 15, 2016

Stakeholder Discussions on PDUFA VI Reauthorization

Industry Discussions on PDUFA Reauthorization

PDUFA Public Meeting July 15, 2015