Eva Temkin, JD
Partner, FDA and Life Sciences
King & Spalding LLP
A partner in our FDA and Life Sciences practice, 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.
Most recently, 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, and she oversaw policy development related to biosimilars and other therapeutic biologics, including development of analytical and clinical data, review and approval of biologics license applications, data reliance, novel technologies and device presentations, exclusivity and life-cycle management considerations, and post-market issues. 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. While at FDA, Eva oversaw the development of numerous guidances and rulemakings.
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. She clerked for Judge John Gleeson on the U.S. District Court for the Eastern District of New York and then worked for several years in private practice, focusing on complex commercial litigation and administrative law matters.