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US FDA ‘Quietly Working Hard’ To Develop Advanced Manufacturing Framework

 
• By Shannon Brown

Soon-to-be-released white papers will FRAME how FDA plans assess products manufactured with advanced technologies as part of an initiative to reduce uncertainty for sponsors.

FDA working on new advanced manufacturing initiative • Source: Alamy

The US Food and Drug Administration is “quietly working hard” to develop a regulatory framework for advanced manufacturing, according to Michael Kopcha, the director of the Office of Pharmaceutical Quality.

Speaking at the Association for Accessible Medicines’ Generics + Biosimilars conference on 8 November, Kopcha said that the program, called...

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