Back to: FDA Generic Drugs Forum 2025
Presenter
Pamela Dorsey, MS, PhD
Senior Pharmacologist, Division of Bioequivalence III (DBIII)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Pamela Dorsey serves as a Senior Pharmacologist for the Division of Bioequivalence III, within the Office of Bioequivalence, Office of Generic Drugs. Dr. Dorsey has experience in assessing bioequivalence for various generic drug products, and currently addresses bioequivalence related controlled correspondences. She has been with the FDA in the Office of Bioequivalence since 2014. She earned a Bachelor of Science and Master of Science in Chemical Engineering from North Carolina Agricultural and Technical State University. In addition, she received her Ph.D. in Pharmaceutical Science from The University of Georgia College of Pharmacy. Before joining the FDA, she was a Ruth Kirschstein Post-doctoral fellow within the Whitaker Cardiovascular Institute at Boston University Medical Center.
Abstract
At the 2025 Generic Drugs Forum, Pamela Dorsey presents on building a global framework for assessing inactive ingredients in generic drug applications. She outlines the FDA’s current approach to evaluating inactive ingredients—including maximum daily exposure (MDE) calculations and population-specific considerations—then compares these practices to those of international regulatory agencies within the generic drug cluster. Through a detailed poll of cluster members, she identifies both commonalities and divergences in assessment methods, such as database use, MDE calculation standards, and evaluation of ingredient grades and context of use. Two case studies underscore the importance of rigorous evaluation, particularly for vulnerable populations. Dorsey concludes by emphasizing the value of international collaboration in aligning regulatory standards and reducing industry burden while maintaining drug safety.