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FDA Science Board Highlights Shortcomings At CDRH

This article was originally published in The Silver Sheet

Executive Summary

CDRH "STRATEGIC PLAN" IMPLEMENTATION will commence in earnest in February after senior center officials meet with an outside management consultant. The Center for Devices and Radiological Health has engaged the services of an organizational development expert to help translate the broad goals of the long-term strategic plan into workable milestones for the center’s various divisions and branches. At the same time, staffers are working to incorporate into the plan recommendations from an external review committee of the FDA Science Board on how to improve the science base of the center. The committee report advocates that CDRH institute major changes in its hiring and training of scientific personnel, use of outside expertise, oversight of combination products and internal assessment

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