Vaishali Popat is an associate director for biomedical informatics and regulatory review science at the FDA. This position recognizes the growing impact and importance of biomedical informatics in the conduct of review work in the Office of New Drugs (OND). Popat is the OND lead on biomedical informatics and safety analysis in areas such as data standards, staff training, and internal and external data sources to make regulatory decisions. With her extensive knowledge of clinical review, medicine, computer science, and information technology, Popat focuses on performing safety analyses and developing recommendations to ensure that CDER effectively responds to the rapidly evolving drug development process.
Previously, Popat, who is an endocrinologist, worked as a medical officer in the Division of Bone, Reproductive and Urologic Products (DBRUP) for the FDA. She enjoys teaching and mentoring new reviewers in the use of new technologies and review tools. Popat received her MD from Union Memorial College.