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  1. Biosimilar User Fee Amendments

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.

BsUFA Public Meeting October 20, 2016

BsUFA Public Meeting December 18, 2015

BsUFA Public Meetings

Industry Discussions on BsUFA Reauthorization

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