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In Brief: CDRH review times

This article was originally published in The Gray Sheet

Executive Summary

CDRH review times: Internal agency report using a "receipt-based" cohort indicates that the FDA Center for Devices and Radiological Health has made strides in improving device submission review times, staffers say. The report's methodology is said to be similar to that used in a Nov. 7 General Accounting Office report highlighting device review delays ("The Gray Sheet" Nov. 13, I&W-4) but with "more sophisticated statistical analysis" of more recent data, FDAers say....



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