Temkin's expertise spans the entire spectrum of FDA-regulated areas
Global law firm Paul Hastings has significantly strengthened its food and drug administration (FDA) and life sciences practice with the strategic hire of Eva Temkin as the chair of the firm’s FDA practice in Washington, DC.
Temkin, who brings nearly a decade of experience in the FDA, recently joined from King & Spalding, enhancing Paul Hastings’ capabilities in regulatory, litigation, and transactional matters related to biomedical products.
Temkin’s expertise spans the entire spectrum of FDA-regulated areas, including drugs, biologics, and combination products. Her role at Paul Hastings will focus on navigating clients through the complex landscape of product development, approval, and post-market regulation. This includes tackling issues related to regulatory exclusivities, manufacturing challenges, digital technologies in drug use, and legislative initiatives such as the Inflation Reduction Act.
Frank Lopez, chair of Paul Hastings, emphasized the importance of having top-tier regulatory talent to navigate the rapidly changing life sciences sector. An evolving life sciences sector "makes it critically important to have premier regulatory talent that understands the life cycle and needs of pharmaceutical and biotech companies," Lopez said.
During her tenure at the FDA, Temkin was instrumental in policy development concerning biological products as the acting director of policy for the Office of Therapeutic Biologics and Biosimilars. She also served as associate chief counsel in the FDA's Office of Chief Counsel, advising on complex biomedical product issues and key legislative initiatives, including the 21st Century Cures Act and over-the-counter monograph reform.
Expressing her enthusiasm for joining Paul Hastings, Temkin highlighted the synergy between her FDA and private practice experience, aiming to leverage this to benefit clients and further the firm’s offerings in the life sciences sector.
Temkin's areas of expertise are broad and deep, covering product development, clinical trials, marketing application strategies, and much more. She is a recognized leader in the field, frequently speaking and writing on FDA regulatory issues. Temkin is an active legal and regulatory community member and serves on boards focused on women's rights and health support services.
