Date:

November 19, 2020

Time:

9:00 AM – 2:00 PM ET



The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. BsUFA authorizes FDA to collect user fees to support the process of review of biosimilar biological products.  The current legislative authority for BsUFA expires in September 2022.  At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. FDA begins the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization.

If you would like to attend the meeting, please register on Eventbrite.

The live virtual public meeting will be webcast at this link: https://collaboration.fda.gov/bsufanov2020/. If you have not used Adobe Connect before, you will be prompted to download the application in order to join.