Professor
University of Maryland
baltimore, Maryland
Dr. James Polli is Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at University of Maryland. His research interest is oral drug absorption, involving laboratory and clinical research. He has served as the advisor to 25 PhD graduates. He is co-Director of the University of Maryland Center of Excellence in Regulatory Science and Innovation and the Center for Research on Complex Generics, each an FDA-funded collaborative agreement with the Agency. He is Director of the online M.S. in Regulatory Science program. He is a fellow of the American Association for Pharmaceutical Scientists (AAPS) and served as an editor of Pharmaceutical Research for 12 years. He is the 14th recipient of the American Pharmacists Association Takeru Higuchi Research Prize. He was the recipient of the 2024 American Association of Colleges of Pharmacy Volwiler Research Achievement Award, the 2024 FFQM Pearls of Bioequivalence Award, the 2022 AAPS Global Leadership Award, and the 2021 TOPRA Education Award. He is a member of the University of Maryland General Clinical Research Center Advisory Committee and the University of Maryland institutional review board (IRB).
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Considerations for Additional Strength Waivers of ANDA Oral Modified-Release Product
Tuesday, November 11, 2025
3:15 PM - 3:30 PM CT