COLEEN KLASMEIER, a partner in the Washington, D.C., office, is ranked among the nation’s top FDA lawyers. She has been a member of the Firm’s Executive Committee since 2015 and served as the Global Coordinator of the Food, Drug and Medical Device Regulatory Practice Area Team from 2010 until 2019.
Since joining Sidley from the Food and Drug Administration (FDA) Office of the Chief Counsel in 2005, Coleen has concentrated her practice on contentious proceedings involving the Agency, and on regulatory strategy and risk management. She has served as regulatory counsel to a wide range of life sciences companies in investigations; civil litigation including product liability, consumer fraud, Hatch-Waxman, and appellate matters; and Congressional investigations. Coleen has testified before Congress on manufacturer communication issues and related constitutional considerations.
Coleen’s recognitions from peers and clients include the 2019 Edition of Chambers USA (Band 1), LMG Life Sciences 2012 and 2019, The Cross-Border Life Sciences Handbook 2007-12, Who’s Who Legal (since 2012), Best Lawyers (2014-19), The Legal 500 US (2011, 2013-17), and Washingtonian (2013 and 2009). She was named Regulatory Attorney of the Year by LMG Life Sciences in 2017.
Coleen has been an adjunct professor at Northwestern University Law School, teaching food and drug law in spring 2014.
Admissions & Certifications
- U.S. Supreme Court
- U.S. Court of Appeals, D.C. Circuit
- U.S. District Court, District of Columbia
- District of Columbia
- Boston University School of Law, J.D., 1996 (magna cum laude)
- McDaniel College (formerly Western Maryland College), B.A., 1993 (summa cum laude)