Eva Temkin

Eva Temkin advises pharmaceutical, biotechnology, and medical device companies on a wide array of issues related to product development, approval, and marketing. Drawing on nearly a decade of experience at the FDA, she routinely advises on FDA engagement and helps clients develop and execute regulatory, legislative, and litigation strategies. Eva serves as lead FDA counsel on complex litigation matters and financial transactions, and she counsels clients through compliance and enforcement issues, implementation of new legal and regulatory mandates, and disputes with FDA.

Eva has extensive experience with the unique issues facing life sciences companies, including the complex FDA regulatory framework and related commercial challenges. 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.