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FDA Quality Assurance Will Catalogue CDER Initiatives To Improve Processes

Executive Summary

The Center for Drug Evaluation & Research's quality assurance unit plans to catalogue different initiatives within the center to standardize and improve processes under newly appointed Associate Director for Quality Assurance Mark Goldberger, MD.

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FDA Education and Outreach Director Mary Pat Couig and Policy & Programs Director Vicki Babb will manage MedWatch following the departure of Medical Director Stephen Goldman, MD, to Knoll Pharmaceuticals and Director Dianne Kennedy to the Office of Drug Evaluation IV (1"The Pink Sheet" Sept. 13, p. 3). FDA is searching for a permanent medical director and hopes to make that appointment before year-end

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