Marian J. Lee

Gibson, Dunn & Crutcher LLP (Washington, DC)

MARIAN J. LEE is a partner in Gibson, Dunn & Crutcher’s Washington, DC office.  As a member of the FDA and Health Care Practice, she provides FDA regulatory and compliance counseling to life science and health care companies.  Ms. Lee has significant experience advising clients on FDA regulatory strategy, risk management, and enforcement actions.  Ms. Lee’s practice spans a broad range of FDA issues, such as product premarket pathways and approvals, good manufacturing practices (GMP) and quality systems (QS), non-clinical and clinical studies, adverse event reporting, recalls, promotion, and scientific communications.  She regularly advises companies during FDA inspections and investigations, and on the crafting of responses to Warning Letters and Form 483 observations.  She has led numerous FDA due diligence assessments for mergers, acquisitions, and other transactions involving life science companies.  Ms. Lee also counsels on FTC regulatory matters relating to the marketing of life science and health care products.  She is a frequent speaker and author on developments in FDA law, including the evolving regulation of digital health, software, and social media.  Law360 selected Ms. Lee as a "Rising Star," one of four attorneys recognized in her field nationwide.  She serves on the Food and Drug Law Institute’s (FDLI) Policy Forum Advisory Board and the Law360 Life Sciences Editorial Advisory Board.  She is a 2012 Fellow to the Leadership Council on Legal Diversity (LCLD).  Ms. Lee graduated from Harvard Law School, where she was an editor of the Harvard Journal of Law and Technology.   She graduated with a Bachelor of Arts, magna cum laude and Phi Beta Kappa, from Harvard College, where she received the Radcliffe College Presidential Award and the David Herbert Donald Prize for her work in American history.  Prior to private practice, she served as a teacher in South Korea through the U.S. Fulbright Program and researched economic policy issues at Harvard Business School.