Amy Hsu

Amy Hsu is a Senior Chemist in the Office of Biotechnology Products (OBP) in FDA/CDER. In her current role, she protects and advances public health by providing risk-based CMC/product quality assessment of therapeutic protein products and biosimilar products from clinical development (IND), licensure (BLA), to post-marketing activities. Amy also participates in manufacturing facility inspections and develops policies and procedures for internal and external stakeholders. She has been a member of the FDA ICH Q14 and Q2(R2) working group. Amy received a Ph.D. in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill and completed postdoctoral training at NIH/NCATS, where she authored over 15 research articles and book chapters in assay/method development, laboratory automation, and chemical informatics.


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