Dr. Kim Benton on finalized guidance for AMT designation program

Today Kim Benton, DHC's Master Principal and Head of Regulatory, published a guest column with cellandgene.com on the finalization of FDA's Guidance on the Advanced Manufacturing Technologies (AMT) Designation Program.

"Among the flurry of FDA guidance for industry releases in the last days of December 2024 was Advanced Manufacturing Technologies Designation Program.1 This finalized the draft guidance from December 2023. How much does the 2024 final guidance advance our understanding of how the Advanced Manufacturing Technologies (AMT) Designation Program will be implemented by FDA and how it can benefit innovators in the cell and gene therapy (CGT) field?

For those not familiar with the program," (click here to continue reading)

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