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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.