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
- March 17, 2016 Steering Committee
- March 24, 2016 Steering Committee
- March 31, 2016 Finance Subcommittee
- March 31, 2016 Steering Committee
- April 7, 2016 Finance Subcommittee
- April 7, 2016 Steering Committee
- April 14, 2016 Finance Subcommittee
- April 14, 2016 Steering Committee
- April 21, 2016 Finance Committee
- April 21, 2016 Steering Committee
- April 28, 2016 Finance Committee
- April 28, 2016 Steering Committee
- May 12, 2016 Finance Committee
- May12, 2016 Steering Committee
- May 19, 2016 Finance Committee
- May 26, 2016 Finance Committee
- May 18-19, 2016 Steering Committee
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Content current as of:
09/23/2024
