FDA Publishes Final Guidance on Advanced Manufacturing Technologies

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FDA published a final guidance on Jan. 2, 2025 for those interested in participating in the agency’s Advanced Manufacturing Technologies Designation Program, which was developed to facilitate drugs manufactured using advanced manufacturing technologies (AMTs). The guidance, Advanced Manufacturing Technologies Designation Program, is the final version of the draft document issued on Dec. 13, 2023.

Early adoption of AMTs that improve the reliability and robustness of manufacturing processes is encouraged by FDA. AMTs can reduce drug development time and may increase the supply of critical drugs, according to the agency. FDA defines “advanced manufacturing” as an “an innovative pharmaceutical manufacturing approach or technology that has the potential to improve the reliability and robustness of the manufacturing process and supply chain and increase timely access to quality medicines. 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” (1).

The Advanced Manufacturing Technologies Designation Program was required under section 506L of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide a framework for those requesting designation of a drug manufacturing method as an AMT. The program provides early interaction opportunities before application submission as a way to encourage adoption of AMTs.

The guidance document details FDA’s Advanced Manufacturing Technologies Designation Program and provides the eligibility criteria for AMT designation. The submission and assessment process for requests is also provided in the document, as well as the benefits related to drug development and application assessment. Details about key concepts for program utilization are available in a Q&A section of the guidance.

“Before submitting an AMT designation request, persons or organizations seeking designation of a method of manufacturing as an AMT (hereinafter requestors) should familiarize themselves with the data requirements described in section 506L of the FD&C Act, the recommendations outlined in this guidance, and other publicly available sources of product development information,” FDA states in the guidance. “Any technology can be considered for AMT designation provided that the technology meets the eligibility criteria described in section 506L(b) of the FD&C Act, the requestor has sufficient data and information to demonstrate eligibility, and the technology is mature enough to consistently and reliably manufacture product in the context of use for which AMT designation is sought.”

Request for AMT designation should include a brief description of the method and why it is a novel method; the context in which the AMT will be used; a description of how the method meets criteria established in section 506L(b) of the FD&C Act; potential regulatory, technical, or other challenges with implementation; anticipated timelines for drug development using the proposed AMT; among other requirements.

“FDA acknowledges that requestors who are not also applicants may not have data about a specific drug to include in their AMT designation request,” the document states. “In these cases, FDA recommends that requestors include data generated using a model drug to provide the agency with a clear understanding of the proposed AMT’s parameters, limitations, and context of use.”

Reference

1. FDA. Advanced Manufacturing Technologies Designation Program, Guidance for Industry (CDER, CBER, December 2024).