AFDO RAPS Healthcare Products Collaborative
BIO
Beth Elizabeth Kunkoski

Elizabeth

Kunkoski

Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER)

FDA

Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving decentralized clinical trials, digital health technologies and electronic records and storage in clinical investigations (Part 11). She previously worked in the Center for Devices and Radiological Health (CDRH) overseeing the review of orthopedic devices. She earned a Master’s Degree in Biomedical Engineering and a Bachelor’s Degree in Chemical Engineering from the University of Michigan.

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The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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