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Diana Vivian, PhD

Acting Associate Director, Division of Bioequivalence II, OB, OGD, CDER

Dr. Diana Vivian joined the Division of Bioequivalence II (DBII) in 2014 and has primarily been involved in the assessment of bioequivalence (BE) data submitted in abbreviated new drug applications (ANDAs). Since 2019, she has served as the Acting Associate Director of DBII. Dr. Vivian has a special interest in areas such as inhalation products, complex topical products, and Biopharmaceutic Classification System (BCS)-based biowaivers. She currently serves on the CDER BCS committee and helped with the Office of Bioequivalence implementation of the 2021 ICH M9 Guidance for Industry on BCS-Based Biowaivers, including assessor training, BE assessment template/summary table revision, etc. 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.

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