SILVER SPRING, Md. — A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.
The FDA announced that it had appointed Mary Beth Clarke as permanent director of the Office of Executive Programs. Clarke had previously served as the OEP's executive director.
FDA Center for Drug Evaluation and Research director Janet Woodcock said Clarke had spearheaded coordination of GDUFA-related activities for the center and the Office of Regulatory Affairs, including development of a project plan for human capital and infrastructure, inspections and compliance and user fee collections.