January 27, 2015
Gibson, Dunn & Crutcher LLP is pleased to announce that Marian Lee has joined the firm’s Washington, D.C. office as a partner. Formerly with King & Spalding, she will continue her U.S. Food and Drug Administration (FDA) regulatory and compliance practice.
“We are pleased to welcome Marian to the firm,” said Ken Doran, Chairman and Managing Partner of Gibson Dunn. “Marian’s FDA regulatory experience will expand our regulatory counseling and compliance capabilities with Life Sciences clients, strengthen our FDA enforcement and litigation practice, and complement the firm’s transactional and intellectual property practices.”
“Marian is a star in the FDA regulatory bar,” said Stephen Payne, Co-Chair of the firm’s FDA and Health Care Practice Group. “She has a well-rounded practice, with extensive experience in the regulation of both medical device and pharmaceutical products over the entire product lifecycle, and in cutting edge issues, such as industry use of social media and the regulation of mobile health technologies.”
“Gibson Dunn offers a compelling mix of legal firepower and a collegial culture,” said Lee. “I look forward to working with the firm’s premier litigation, enforcement, and transactional practices to serve our life science and health care clients.”
About Marian Lee
Lee provides FDA regulatory and compliance counseling to life science and health care companies. She has significant experience advising clients on FDA regulatory strategy, risk management, and enforcement actions. Her practice spans a broad range of FDA issues, such as product premarket pathways and approvals, good manufacturing practices and quality systems, inspections, non-clinical and clinical studies, adverse event reporting, recalls, promotion, and scientific communications. For life science transactions, Lee regularly leads the due diligence on FDA compliance. She is a frequent speaker and author on developments in FDA law, including the evolving regulation of social media, mobile health, and health information technologies.
Lee serves on the Law360 Life Sciences Editorial Advisory Board and the Food and Drug Law Institute’s (FDLI) Policy Forum Advisory Board. She graduated from Harvard Law School, where she was an editor of the Harvard Journal of Law and Technology, and from Harvard College.