Lexology January 17, 2025
Sidley Austin LLP

In December 2024, the U.S. Food and Drug Administration (FDA) released its finalized guidance on the Advanced Manufacturing Technologies (AMT) Designation Program, marking a significant milestone in the agency’s efforts to modernize pharmaceutical manufacturing. This program is designed to facilitate the adoption of innovative manufacturing technologies that can enhance drug quality, ensure a robust supply chain, and expedite the development and availability of critical medications.

This guidance finalizes the draft guidance of the same title issued on December 13, 2023. FDA considered comments received on the draft guidance and in response made changes to the final guidance including clarifying the following:

  • the process of submitting a request for AMT designation to FDA
  • description of eligibility criteria to receive AMT...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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