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Advanced Manufacturing May Require US FDA To Think Differently About Guidance

 
• By Grace Moser

National Academies report argues that technologies cannot only be evaluated in the context of specific products, and FDA guidance should become both ‘more fluid and targeted.’

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The US Food & Drug Administration should “consider more fluid and targeted guidance” to provide perspective advanced manufacturing technologies outside of individual product approvals, the National Academies of Science, Engineering & Medicine urges in a set of recommendations detailed in a new report.

The recommendation reflects concern that the Center for Drug Evaluation & Research’s “ability to foster innovation is fundamentally constrained by the center’s formal evaluation of technology only as it applies...

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