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  5. BsUFA II: Fiscal Years 2018 - 2022
  1. Biosimilar User Fee Amendments

BsUFA II: Fiscal Years 2018 - 2022

The current legislative authority for BsUFA, authorized in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA) will expire in September 2017. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA hold public meetings and conduct discussions with both the regulated industry in developing recommendations for the next BsUFA program (FY2018-2022).

This page contains information for both the public part of the BsUFA reauthorization process and the discussions FDA holds with industry.

Implementation

BsUFA II Legislation

BsUFA II Commitment Letter

BsUFA II Reauthorization Proposed Enhancements Public Meeting - October 20, 2016

BsUFA II Reauthorization Kickoff Public Meeting - December 18, 2015

Industry Discussions on Reauthorization

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