WASHINGTON (February 26, 2024) - Paul Hastings announced today the arrival of leading FDA/life sciences partner Eva A. Temkin in Washington, D.C., as chair of the firm's FDA practice.

Joining from King & Spalding LLP, Temkin's practice focuses on regulatory, litigation, and transactional matters involving biomedical products regulated by the Food and Drug Administration (FDA). Leveraging nearly a decade of prior experience at the FDA, she helps clients problem-solve and execute strategies related to drugs, biologics, and combination products from development and approval through post-market regulation.

"The rapidly evolving life sciences sector, particularly in the sphere of the FDA, makes it critically important to have premier regulatory talent that understands the life cycle and needs of pharmaceutical and biotech companies," said firm Chair Frank Lopez. "Eva's strong FDA experience and market credibility, paired with our existing life sciences team, will be instrumental to enhancing our life sciences, corporate, and litigation practices. We are thrilled that she has joined us."

Temkin works on matters spanning product development and clinical trials, regulatory exclusivities, orphan drugs issues, manufacturing and facilities issues, post-approval study requirements and REMS, drug-use-related software and digital technologies, licensing and supply arrangements, the Administrative Procedure Act, and the Inflation Reduction Act.

"I'm excited to join this sophisticated practice and contribute to the firm's continued focus on serving key industry sectors," said Temkin. "My FDA and private practice experience creates synergies that will benefit my clients while also enhancing the firm's offerings."

At the FDA, Temkin led policy development across a broad spectrum of issues relating to biological products as acting director of policy for the Office of Therapeutic Biologics and Biosimilars. As associate chief counsel at the FDA's Office of Chief Counsel, she provided strategic direction to the agency's regulators on complex biomedical product issues and legislative initiatives, including the 21st Century Cures Act and over-the-counter monograph reform.

Paul Hastings' interdisciplinary life sciences and healthcare practice helps clients protect and enhance the value they deliver to the healthcare marketplace. The practice has partnered with companies ranging from early-stage innovators to some of the world's largest life sciences manufacturers and healthcare providers in areas including compliance program assessments and enhancements, high-stakes litigation, multifaceted government compliance, fair market value matters, investigations and enforcement issues, and complex cross-border transactions.

About Paul Hastings
With widely recognized elite teams in finance, mergers & acquisitions, private equity, restructuring and special situations, litigation, employment, and real estate, Paul Hastings is a premier law firm providing intellectual capital and superior execution globally to the world's leading investment banks, asset managers, and corporations. For more information, visit www.paulhastings.com.

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