Marian J. Lee is a partner in Gibson, Dunn & Crutcher’s Washington, D.C. office. 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. She has led an array of legal assessments across the FDA-regulated industry during government investigations and corporate transactions.
Ms. Lee's practice spans the product life cycle, including the conduct of pre-clinical and clinical studies, good manufacturing practices (GMP) and quality systems (QS), premarket approvals and clearances, scientific communications, product labeling and advertising, and post-market compliance. She also counsels on FTC matters relating to the marketing of foods, cosmetics, over-the-counter (OTC) drugs, medical devices, and other health care products. She is a frequent speaker and author on developments in FDA and FTC law, such as the evolving regulation of product promotion, digital health, and hemp-based products.