New FDA Designation Approves First AMT Program

Published on Cell & Gene

The U.S. FDA has approved the first product under its new Advanced Manufacturing Technology (AMT) designation, a move that could shape how cell and gene therapies are evaluated for manufacturing innovation. This article outlines what the designation means, how it supports regulatory review, and what it implies for future products in the pipeline.

Read the full article on Cell & Gene:

👉 First AMT Program OK’d Under New FDA Designation - Here’s What To Know

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