0910-AH55 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Post Approval Changes to Approved Applications

The proposed rule would update the existing regulations governing supplements and other changes to approved new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), as well as regulations regarding certain post-approval reports.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 314.70 21 CFR 314.81 21 CFR 601.12 21 CFR 601.70 21 U.S.C. 355 42 U.S.C. 262 No NPRM 12/00/2023 No Businesses Federal No No No No Ashley Boam Health Science Administrator 0910 Food and Drug Administration FDA 301 796-6341 ashley.boam@fda.hhs.gov Center for Drug Evaluation and Research, Building 51, Room 4192, 10903 New Hampshire Avenue, Silver Spring MD 20993