Theresa Chan, PharmD

Regulatory Health Project Manager, OB, DBPM, OGD, CDER

Dr. Theresa Chan is currently a regulatory project manager in the Office of Generic Drugs specifically managing bioequivalence application submissions and related processes. She graduated from Rutgers University, Ernest Mario School of Pharmacy, with a Pharm.D. in 2018. Starting as an ORISE research fellow, she gained experience and training in pharmaceutics research, regulatory health project management and Generic Drug User Feed Amendments (GDUFA) science and research program. She has since transitioned to focusing on coordinating and monitoring the bioequivalence review cycle for applications along with leading communications within and outside of FDA and resolution of challenging scientific issues.

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