AFDO RAPS Healthcare Products Collaborative
BIO
Thinh Nguyen

Thinh

Nguyen

Director, Office of Clinical Policy and Programs

FDA

Thinh Nguyen has been with the FDA since 2008, first as Director of the Office of Combination Products (OCP) and now as Director of the Office of Clinical Policy and Programs. He oversees jurisdictional determinations, premarket reviews, post-market regulations, and policy development. Previously, he was Director for the Premarket Approval Section at the Center for Devices and Radiological Health, contributing to key legislations like MDUFMA and MDUFA. Before the FDA, Nguyen was a senior electronics engineer at the Naval Electronics Systems Engineering Center. He holds a bachelor's degree in electrical engineering from North Carolina State.

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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