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US FDA Program Adds Staff, Graduation Concept To Help Advance Newer Manufacturing Technologies

 
• By Shannon Brown

Agency will expand staffing to address requests for help from its Emerging Technology Program, while “graduating” technologies with which it gains sufficient experience.

Graduation cap
a diploma for emerging technologies • Source: Alamy

To further accelerate adoption of new pharmaceutical manufacturing technologies, the US Food and Drug Administration’s Center for Drug Evaluation and Research is adding staff to its Emerging Technology Program and “graduating” technologies to standard quality assessment pathways.

Larry Lee, who chairs the program, told the FDA’s Pharmaceutical Quality Symposium on 27 October that the changes are part of an effort to “create a more efficient program that...

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