For Industry

BsUFA Meetings

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 December 18, 2015

On December 18, 2015, FDA is holding a public meeting to discuss the reauthorization of BsUFA. To register for this meeting, click the registration link below. Registration will close on November 18, 2015.

BsUFA Public Meetings

The minutes of meetings between FDA and the regulated industry are posted below.

Page Last Updated: 03/23/2018
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