Lexology January 29, 2024
On December 12, 2023, the Food and Drug Administration (“FDA”) issued a draft guidance titled the “Advanced Manufacturing Technologies Designation Program” (“AMT Draft Guidance”), which introduces a new program established by the Food and Drug Administration Omnibus Reform Act (“FDORA”) for designating specific methods for manufacturing drugs, biological products, and active pharmaceutical ingredients (“APIs”) as advanced manufacturing technologies (“AMT”).1 The goal of the program is to facilitate the development of drugs manufactured using an AMT. This Alert summarizes the new draft guidance, which details the eligibility criteria for the program, the expected content of designation requests, the designation review process, and the benefits of the program.
The AMT Draft Guidance reflects the agency’s latest effort to encourage the use of...
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