Download Ashley Boam - Product Quality Research Institute

Ashley Boam currently serves as acting Deputy Director of the Office of Pharmaceutical Science
in the Center for Drug Evaluation and Research (CDER). Prior to joining CDER, Ashley spent
nearly 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and
Radiological Health (CDRH). During her nine year tenure as Branch Chief of the Interventional
Cardiology Devices Branch, her responsibilities included oversight of clinical trials of and
marketing applications for coronary drug-eluting stents, cardiac occluders to correct congenital
heart defects, and other interventional devices. She was also involved in the initial development
of the Medical Devices User Fee and Modernization Act and renewal of that program in 2012
(MDUFA III). Ashley also served as Associate Director for Regulations and Guidance for ODE,
where she played a significant role in the planning and development of regulatory and guidance
initiatives. As acting Deputy Director of OPS, Ashley focuses on regulatory and policy issues
related to pharmaceutical quality assessment, including application review and interactions with
compendial and international standards-setting organizations. She also remains significantly
involved in policy issues related to drug-device combination products. Ashley received her MSBE
from the University of Alabama at Birmingham and her BSE from Tulane University, both in
Biomedical Engineering.