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FDA’s Goodman Is Rising Star Within Agency As Obama Team Coalesces

Executive Summary

FDA's top biologics review manager Jesse Goodman is taking on a more prominent role within the agency and HHS as FDA realigns its management in anticipation of the arrival of Commissioner-designate Margaret Hamburg and her principal deputy Joshua Sharfstein

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Janet Woodcock's move to become director of the Center for Drug Evaluation and Research illustrates the operational challenges FDA faces: The agency remains deeply committed to its historic bargain with the drug industry to take user fees in order to improve application review, but it is finding it increasingly hard to meet deadlines or to perform any other outside projects

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