0910-AI14 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Biologics Regulation Modernization

FDA’s biologics regulations will be updated to clarify existing requirements and procedures related to Biologic License Applications and to promote the goals associated with FDA’s implementation of the abbreviated licensure pathway created by the Biologics Price Competition and Innovation Act of 2009.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 601 42 U.S.C. 262 21 U.S.C. 301, et seq. Yes NPRM 04/00/2024 Undetermined None Undetermined No No Sandra Benton Senior Policy Coordinator 0910 Food and Drug Administration FDA 301 796-1042 sandra.benton@fda.hhs.gov 10903 New Hampshire Avenue, Building 22, Room 1132, Silver Spring MD 20993