November 9-11, 2020 | Virtual Conference


Eva Temkin, J.D.

Acting Associate Director for Policy, Office of Therapeutic Biologics and Biosimilars, CDER

Eva Temkin is the Acting Director for Policy in the Office of Therapeutics and Biologics within FDA’s Center for Drug Evaluation and Research. In this role, she oversees the development and implementation of policy related biological products, including biosimilar and interchangeable biologic products. As agency lead for FDA’s Biosimilar Action Plan, which outlines the Administration’s plans for encouraging innovation and competition among biologics and the development of biosimilars, Ms. Temkin works on a variety of subjects related to competition and patient access.
Prior to joining the Office of Therapeutic Biologics and Biosimilars, Ms. Temkin was Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel, providing counseling to Agency components working on numerous biomedical products issues, ranging from expedited pathways and questions of data development and evidentiary standards to over-the-counter monograph reform. Previously, Ms. Temkin was a litigator at the law firms of Cravath, Swaine & Moore LLP and Robbins, Russell, Englert, Orseck, Untereiner & Sauber LLP and a law clerk in the United States District Court for the Eastern District of New York. She earned her J.D. from New York University School of Law, where she was the NYU Law and Economics Fellow, and her B.A. in economics from the University of Michigan.

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