Back to: FDA Generic Drugs Forum 2025
Presenter
Diana Vivian, PhD
Associate Division Director
Division of Bioequivalence II (DBII) Office of Bioequivalence (OB) Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Diana Vivian joined the Division of Bioequivalence II (DBII) in 2014 and has served as the Associate Director of DBII since 2019. Dr. Vivian has bioequivalence interests in diverse areas such as complex topical dosage forms, nasal and inhalation products, and the Biopharmaceutics Classification System (BCS). She is currently the co-chair of the CDER wide BCS Committee. She received her Bachelor of Science degree in Chemical Engineering from the University of Maryland, College Park and her Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore.
Abstract
At the 2025 Generic Drugs Forum, Diana Vivian presents on the impact of ICH M13A guidance on bioequivalence (BE) assessment, focusing on the removal of data due to low exposure. She outlines the guidance’s recommendation to avoid excluding BE data solely based on statistical outliers, with rare exceptions for cases of extremely low drug exposure likely caused by subject noncompliance. Vivian contrasts past FDA practices with the new framework in M13A, which permits exclusion only when a subject’s AUC is less than 5% of the geometric mean AUC and provides case studies demonstrating how these principles were applied to both immediate and modified release products. Emphasizing a totality-of-evidence, risk-based approach, she highlights that exclusions must be scientifically justified, infrequent, and not suggest product failure. The session concludes with challenge questions reinforcing key points and acknowledgment of colleagues who contributed to the analysis.