Health Science Administrator

0910-AI88 202410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Amendments to the Current Good Manufacturing Practice Regulations for Drug Products

FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products. The proposed amendment will clarify and modernize the regulations by adding requirements for quality management systems and controls over components and drug product containers and closures.

]]> Section 3(f)(1) Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes Private Sector 21 CFR 210 21 CFR 211 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 355 21 U.S.C. 360b 21 U.S.C. 360bbb-7 21 U.S.C. 371 21 U.S.C. 374 42 U.S.C. 262 42 U.S.C. 264 No NPRM 10/00/2025 YES Businesses None No Yes 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