Coleen Klasmeier leads the firm’s food, drug and medical device regulatory practice within the global life sciences team, managing matters on behalf of 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 FDA litigation and dispute resolution, and on regulatory strategy and risk management. 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.
In addition to serving as the leader of Sidley’s food, drug and medical device regulatory practice, Coleen is a member of the firm’s executive committee and diversity committee. She also chairs the Washington, dc practice development committee.
Coleen is a member of the Washington Legal Foundation’s legal policy advisory board. She is also past chair of the food and drug committee of the American Bar Association’s section on administrative law and agency practice. Coleen formerly served 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.
WWL says: “A dedicated and assiduous counsel.”
This biography is an extract from Who's Who Legal: Life Sciences which can be purchased from our Shop.
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Nominees have been selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. Only specialists who have met independent international research criteria are listed.