Lexology December 20, 2023
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program.
With the enactment of the 2022 omnibus spending bill, the US Congress mandated FDA to establish an AMT program for manufacturing methods that incorporate a novel technology or use an established technology in a unique way to produce a drug of equivalent or superior quality.
Advanced manufacturing, which generally is the use of innovative or emerging technologies to improve the drug manufacturing process, is viewed by FDA...
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