Association for Accessible Medicines
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Dr. Chyong-Yi Wu is a Regulatory Health Project Manager in Division of Bioequivalence Process Management (OBPM), Office of Bioequivalence (OB), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER) at FDA. Dr. Wu oversees the review team responsible for evaluating generic drug applications under the GDUFA program. Her tasks involve team coordination and planning to ensure successful execution of various concurrent activities. Prior to her role at FDA, Dr. Wu served as an Assistant Research Professor at the University of Maryland. Her research spanned developmental biology, cellular immunology, and cancer biology. She earned her MS and Ph.D. in Biology from the University of Alabama and completed post-doctoral trainings at the University of California, San Diego, University of Houston, and University of Maryland.