The FDA has issued final guidance for its Advanced Manufacturing Technologies (AMT) Designation Program, a framework aimed at encouraging the use of innovative manufacturing approaches in drug production.
Published on Jan. 2, 2025, the document provides updated eligibility criteria and submission guidelines, building on a draft released in December 2023.
Advanced manufacturing methods, which integrate novel technologies or adapt established processes in groundbreaking ways, are designed to enhance the reliability, speed, and flexibility of drug production. The FDA notes that such innovations could reduce development timelines and help ensure a steady supply of critical medicines.
The AMT Designation Program, established under Section 506L of the Federal Food, Drug, and Cosmetic Act, offers early-stage support for companies developing qualifying technologies. Applicants must submit detailed proposals, including descriptions of the technology's novelty, its application context, and the challenges it might face during implementation.
To assist stakeholders, the guidance outlines data requirements, assessment procedures, and program benefits. A Q&A section clarifies key concepts, while the FDA emphasizes the importance of providing robust data — either from an approved drug or a model drug —demonstrating the method’s feasibility and reliability.