0910-AJ31 202510 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 21 CFR Parts 210 and 211; Current Good Manufacturing Practices; Advanced Manufacturing, Distributed, and Point of Care Manufacturing

The Food and Drug Administration (FDA) is proposing to amend the current good manufacturing practice (CGMP) regulations in 21 CFR parts 210 and 211 (drugs) and 600-800 (biologics) to clarify their application to advanced manufacturing technologies, including continuous manufacturing, distributed manufacturing, and point-of-care manufacturing. The proposed amendments would clarify how manufacturers may apply a science- and risk-based approach to CGMP compliance when using advanced manufacturing technologies, including flexible approaches to defining batches, modern control strategies based on real-time monitoring and material traceability, and lifecycle-based validation and process verification. FDA is also proposing to clarify CGMP expectations for manufacturing drugs produced in small quantities, including drugs for rare diseases. These proposed amendments build on Section 3213 of the Food and Drug Omnibus Reform Act of 2022 (FDORA), which amended the Federal Food, Drug, and Cosmetic Act, in part, to add section 506L (21 U.S.C. 356l), including FDA’s Advanced Manufacturing Technologies Designation Program, to facilitate a framework for development and manufacturing of drugs.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Deregulatory 21 CFR 210 21 CFR 211 21 USC 321 21 USC 351 21 USC 352 21 USC 355 21 USC 360b 21 USC 371 21 USC 374 No NPRM 07/00/2026 Undetermined Undetermined Undetermined No No Lowell Zeta Deputy Commissioner of Strategic Initiatives 0910 Food and Drug Administration FDA 301 332-8931 lowell.zeta@fda.hhs.gov 10903 New Hampshire Avenue, WO Building 1, Room 2314, Silver Spring MD 20993