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), inspections, non-clinical and clinical studies, adverse event reporting, recalls, promotion, and scientific communications. For life science transactions, she regularly leads the due diligence on FDA compliance. Ms. Lee also advises 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 social media, mobile health, and health information technologies. 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.
Areas of Practice
Drug & Medical Device
Food & Beverage
Science & Technology
Biotechnology, medical device, life sciences
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