WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments.
The notice was published in the Federal Register on Nov. 24 by Lowell M. Zeta, Acting, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in Septem...