Eva A. Temkin

Eva Temkin is Chair of the FDA practice at Paul Hastings and is based in the firm’s Washington, D.C. office. Drawing on nearly 20 years of practice, including almost a decade at FDA, Eva advises pharmaceutical, biotechnology, and medical device companies on a wide array of issues faced by FDA-regulated industry. In both pre-market and post-market arenas, Eva helps clients develop and execute FDA engagement strategies and problem-solve issues through regulatory, legislative, and litigation strategies. She has counseled clients through formal and informal FDA dispute resolution proceedings, been the regulatory lead for numerous financial transactions, and served as lead FDA counsel on several complex litigation matters.

Eva has deep expertise on the unique issues facing biological products (e.g., vaccines, cell and gene therapies, immune modulators, monoclonal antibodies, and biosimilars). She previously acted as Director for Policy at the FDA’s Office of Therapeutic Biologics and Biosimilars, where she was the Agency lead for development and implementation of therapeutic biologics and biosimilars policy. 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 the 21st Century Cures Act and over-the-counter monograph reform.

Eva’s other areas of particular focus include:

• Product development, clinical trials (including use of digital health tools and study diversity), real-world evidence, and other data generation issues
• Marketing application approval and expedited program designation strategies
• Regulatory exclusivities, orphan-drug designation, and pediatric study programs
• Manufacturing and facilities issues and remediation
• Post-approval study requirements and risk mitigation strategies
• Product jurisdiction and combination products
• Prescription drug-use-related software and other digital technologies
• Clinical trial and licensing and supply agreements
• Agency jurisdiction and the Administrative Procedure Act
• Preemption under the Federal Food, Drug, and Cosmetic Act
• The Inflation Reduction Act

Eva is a frequent speaker and author on FDA regulatory issues and a contributor to multiple academic publications on accelerated approval, drug and biologics regulation, and biosimilars. She serves on the Law360 Life Sciences Editorial Advisory Board and the Food and Drug Law Institute (FDLI) Medical Products Committee. She is also on the Leadership Advisory Board for the National Women’s Law Center and on board of Hope Connections.

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 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.