Coleen Klasmeier leads the firm’s Food, Drug and Medical Device Regulatory practice within the global Life Sciences team, managing matters on behalf of the world’s leading biopharmaceutical, medical technology and food and consumer product companies. Since joining Sidley from the office of the chief counsel at the Food and Drug Administration in 2005, Coleen has concentrated her practice on regulatory strategy and risk management, and on FDA litigation and dispute resolution. She has been deeply involved as FDA regulatory counsel in defending numerous off-label marketing investigations, as well as in a wide variety of product liability, consumer fraud, Hatch-Waxman, criminal and appellate matters on behalf of life sciences industry clients.Coleen serves as FDA regulatory counsel to such companies as GlaxoSmithKline, Kimberly-Clark and Roche Diagnostics. Coleen’s work has been published in legal and policy journals and was cited by the Second Circuit in the 2012 Caronia decision involving First Amendment limitations on FDCA misbranding prosecutions. Coleen is the author of FDA Advertising and Promotion Manual (with Wayne Pines) and numerous other publications. Coleen is a member of the firm’s diversity committee and leads its Washington, DC practice Development Committee. She is also a member of the Washington Legal Foundation’s Legal Policy Advisory Board. She is past chair of the food and drug committee of the American Bar Association’s section on administrative law and agency practice. She is on the Center for Communications Compliance Advisory Board. Her memberships include the FDA Alumni Association, DIA, Women in Bio and the Food and Drug Law Institute.
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