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CDRH Review Times May Increase If Industry Does Not Utilize "Efficiencies"

This article was originally published in The Gray Sheet

Executive Summary

Industry hesitation to adopt FDA's recently revamped premarket procedures could aggravate an expected increase in review times, topsiders from FDA's Center for Devices and Radiological Health warned attendees of the Food & Drug Law Institute's 42nd Annual Educational Conference Dec. 16 in Washington, D.C.

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