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# Advanced Manufacturing Technologies Guidance
- URL: https://www.fdaweb.com/advanced-manufacturing-technologies-guidance/
- Published: 2023-12-12T12:00:00.000Z
- Updated: 2026-09-14T14:18:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155971

FDA has published a draft guidance, *Advanced Manufacturing Technologies Designation Program*, with recommendations for persons and organizations interested in participating in the agency’s Advanced Manufacturing Technologies (AMT) Designation Program, which is intended to facilitate the development of drugs manufactured using an AMT that has been designated under the program. The [document](https://www.fda.gov/media/174651/download?ref=fdaweb.com) outlines the eligibility criteria for AMT designation, the submission and assessment process for requests, and the benefits of receiving an AMT designation. It includes a Question and Answer section to cover additional details about key concepts important for program use.

Specifically, FDA says, the draft describes:

- the process for submitting an AMT designation request, including a description of eligibility criteria and the data and other information to be included;
- when and how FDA will communicate receipt of and provide advice on an AMT designation request;
- when and how FDA will assess AMT designation requests;
- the process by which FDA will engage with holders of designated AMTs and applicants for drugs manufactured using, referencing, or relying upon a designated AMT; and
- potential benefits related to drug development and application assessment.