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Final Program


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Xiaofei Wang, PhD

Clinical Pharmacologist, CBER/OTP/Office of Clinical Evaluation/Div of General Medicine
US Food & Drug Administration

Dr. Xiaofei Wang is currently a clinical pharmacology reviewer in the Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA). She performs clinical pharmacology reviews for BLA and IND submissions of biological products including cell and gene therapies, blood- and plasma-derived products. Dr. Wang previously served as a bioequivalence reviewer in Office of Bioequivalence (OB), Office of Generic Drugs (OGD), Center for Drugs Evaluation and Research (CDER), FDA. In addition to conducting regulatory reviews, Dr. Wang has also actively participated in multiple FDA working groups developing regulatory guidances for drug products. Dr. Wang received her PhD degree in Pharmaceutical Sciences from University of Florida.

Presentation(s):

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