Lexology December 15, 2023
On Tuesday, the U.S. Food and Drug Administration (FDA) launched a new program for entities using or developing advanced manufacturing technologies that is intended to expedite development and assessment of applications for drugs and biologics that are manufactured using innovative pharmaceutical manufacturing technology or approaches that have the potential to improve the reliability and robustness of the manufacturing process and supply chain. The Advanced Manufacturing Technologies (AMT) Designation program was announced in draft guidance that explains how sponsors granted an AMT designation will have prioritized and more frequent communications with FDA, which may improve the chances of regulatory success throughout the drug development lifecycle. In the article below, we summarize what qualifies as an AMT under the draft guidance and...
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