The current legislative authority for BsUFA, authorized in 2017 by the Food and Drug Administration Reauthorization Act (FDARA) will expire in September 2022. 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 (FY2023-2027).

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