• June 3-6, 2024
  • San Diego Convention Center, California


Eva Temkin

Eva Temkin, JD

Arnold & Porter
Eva provides strategic counsel to clients regarding significant and complex issues associated with FDA-regulated biomedical products. Eva draws upon her deep experience with these products at FDA to help clients navigate development, approval, post-market regulation and life-cycle management of drugs and biologics, biosimilars, and combination products. Eva acted as Director for Policy at the FDA’s Office of Therapeutic Biologics and Biosimilars. In that position, Eva was the Agency lead for the Biosimilars Action Plan, FDA’s roadmap for building a competitive market for innovator biologics and biosimilars. Additionally, as Associate Chief Counsel at the FDA’s Office of Chief Counsel, Eva provided strategic counseling to government regulators on a wide range of biomedical-product issues and legislative initiatives, including data development and evidentiary standards, expedited approval pathways, product jurisdiction, patient focused drug development, real world evidence, drug supply chain security, and over-the-counter monograph reform. Eva earned her undergraduate degree from the University of Michigan and her J.D. from New York University School of Law, where she was the Law and Economics Fellow (merit-based full-tuition award) and editor of the NYU Annual Survey of American Law.
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