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FDA safety alert procedures need better coordination, BioStar exec tells AMDM.

This article was originally published in The Gray Sheet

Executive Summary

FDA SAFETY ALERT COORDINATION WOULD BENEFIT INDUSTRY by providing a concerted agency message instead of separate communications from the Compliance and Device Evaluation offices in FDA's Center for Devices and Radiological Health, Roger Briden, BioStar director of regulatory affairs, asserted Oct. 21 at the Association of Medical Diagnostic Manufacturers annual meeting in Washington, D.C.



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