Eva Temkin

Eva Temkin works with pharmaceutical, biotechnology, and medical device companies on a wide array of issues related to product development, approval, and marketing. Drawing on nearly 20 years of practice, including almost a decade at the FDA, she works with clients to develop and execute regulatory, legislative, and litigation strategies. She also advises clients with respect to the Inflation Reduction Act and other new and evolving mandates affecting FDA-regulated products. Eva 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 extensive experience with the unique issues facing biological products, including cell and gene therapies, in addition to a wide variety of drugs and devices. During her tenure at FDA, Eva served as the agency’s lead for development and implementation of therapeutic biologics and biosimilars policy. Additionally, she provided strategic counseling to government regulators on a wide range of biomedical-product issues and legislative initiatives. Eva is a frequent speaker and author on FDA regulatory issues and a contributor to multiple academic publications.