Advanced Manufacturing Technologies (AMT) Designation Program Guidance for Industry

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Advanced manufacturing is a term for an innovative pharmaceutical manufacturing technology or approach that has the potential to improve the reliability and robustness of the manufacturing process and supply chain and increase timely access to quality medicines for the American public.

Advanced manufacturing can integrate novel technological approaches, use established techniques in an innovative way, or apply production methods in a new domain where there are no defined best practices or experience.

Advanced manufacturing can potentially be used for new or currently marketed small molecule drugs or biological products.

FDA’s Advanced Manufacturing Technologies Designation Program, which is required under section 506L of the Federal Food, Drug, and Cosmetic Act (FD&C Act), offers a framework for persons or organizations (e.g., applicants, contract manufacturers, technology developers) to request designation of a method or combination of methods of manufacturing a drug as an AMT.

The program is intended to facilitate the development of drugs that are manufactured using a designated AMT, submitted in an application under section 505 of the FD&C Act (21 68 U.S.C. 355) or section 351 of the Public Health Service Act (PHS Act, 42 U.S.C. 262), and regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The holder of the AMT designation or another authorized party may reference or rely upon data or information about the designated AMT in an application in the same context of use for which the designation was granted.

FDA will expedite development and assessment of an application, including supplements, for drugs that are manufactured using a designated AMT as described in section 506L(d)(1) of the FD&C Act

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