Speakers

Xiaoming Xu, Ph.D., serves as Division Director in the Office of Pharmaceutical Quality Research (OPQR) at the U.S. Food and Drug Administration (FDA). In this role, he oversees multiple regulatory science initiatives focused on complex formulations, nanomaterials, and advanced manufacturing. Dr. Xu plays a leading role in the implementation of the Generic Drug User Fee Amendments (GDUFA) III, serving as co-lead of the Complex Product-Specific Guidance (PSG) Working Group, where he promotes the integration of regulatory research into PSG development for complex drug products. He is an active member of the FDA Nanotechnology Task Force and leads international collaborations and standards development in the area of nanotechnology-enabled products. Dr. Xu is an editorial board member of the International Journal of Pharmaceutics and an elected Fellow of the Controlled Release Society (CRS) and the American Association of Pharmaceutical Scientists (AAPS). He holds a B.S. and M.S. in Pharmaceutics from China Pharmaceutical University and earned his Ph.D. in Pharmaceutical Sciences from the University of Connecticut.