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Ashley Boam (she/her/hers)

Director, Office of Policy for Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER)
FDA, Maryland, United States

Ashley Boam, MSBE serves as Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug quality, including application assessment and inspection. OPPQ also coordinates OPQ’s work with international regulatory authorities on quality issues, leads CDER’s compendial operations, coordinates CDER’s involvement in quality standard-setting organizations, and addresses policy issues related to drug-device combination products.

Prior to joining CDER in 2013, Ashley spent nearly 20 years in the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health (CDRH). She has also participated as an Agency negotiator in multiple user fee negotiations with regulated industry, including the Medical Device User Fee Amendments (MDUFA), the Generic Drug User Fee Amendments (GDUFA), and the Over-the-Counter Drug User Fee programs (OMUFA).

Ashley received her MSBE from the University of Alabama at Birmingham and her BSE from Tulane University, both in Biomedical Engineering.

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