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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