In addition to developing premarket strategies for developers of innovative drugs and medical devices, Coleen has served as FDA regulatory counsel in defending many off-label marketing investigations, and has served as regulatory counsel on Lanham Act, securities, mass tort/product liability, consumer fraud, Hatch-Waxman, criminal, and appellate matters on behalf of life sciences industry clients.
Coleen's policy practice focuses on reforming the regulatory environment for the communication of information about FDA-regulated products and increasing efficiency and transparency in FDA's regulatory review processes.
Coleen's work has been published in legal and policy journals and was cited by the Second Circuit in a seminal 2012 decision involving First Amendment limitations on off-label marketing prosecutions. She is a member of the Washington Legal Foundation's legal policy advisory board and past chair of the food and drug committee of the American Bar Association's agency law section. She is an advisory board member for the Center for Communications Compliance and author of the FDA Advertising and Promotion Manual (Thompson Publishing). Her memberships include the FDA Alumni Association, Women in Bio, and the Food and Drug Law Institute.
Coleen is listed as a leader in Life Sciences: Regulatory/Compliance and Healthcare: Pharmaceutical/Medical Products Regulatory in Chambers USA and is named a 'life sciences star' in the inaugural edition of LMG Life Sciences. She is also highly ranked by The Practical Law Company in The Cross-Border Life Sciences Handbook; the Legal 500 United States; and Who's Who Legal.
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