Mark Heller serves as chair of the firm’s FDA Group and is a member of the Life Sciences Practice. He focuses on the Food and Drug Administration’s and Federal Trade Commission’s laws and regulations, and in the FDA context, assists clients with strategy development, the premarket submission process, compliance issues, enforcement matters, development of legislation, and administrative and judicial appeals.

Areas of Practice
Tätigkeitsfelder
业务范围

Experience

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工作经历

Professional Experience

Prior to joining Goodwin in 2007, Mr. Heller was chair of the FDA Department at WilmerHale. Before that, he spent almost 10 years in the FDA’s Chief Counsel’s office, where he was actively involved in offensive and defensive litigation, including drug and device cases. During his last six years with the FDA, Mr. Heller was the Associate Chief Counsel for Medical Devices, responsible for the legal aspects of the agency's combination product, device enforcement, premarket notification, investigational device exemption, reclassification and premarket approval programs. He also was involved in the development of the Safe Medical Devices Act of 1990 while on detail to the office of the chairman (Senator Edward M. Kennedy) of the Senate Committee on Labor and Human Resources.

Before joining the FDA, Mr. Heller was with the Federal Trade Commission for eight and a half years. He focused on the regulation of food, drug and device advertising. Mr. Heller has received several awards for excellence for his work at both the FDA and FTC.

Recognition

Mr. Heller has been listed in Chambers USA: America’s Leading Lawyers for Business (Band 1) from 2006 to 2016, U.S. News–Best Lawyers from 2007 to 2017, named as an LMG Life Sciences Regulatory Star (2016) and The Legal 500 U.S (2014). He has been prominently featured as one of three “leading” lawyers in the 2006/2007 and 2008/2009 editions of PLC Cross-border Life Sciences Handbook in the USA Regulatory [Medical Devices] category, and again recognized by PLC in the 2010/2011 Cross-border Life Sciences Handbook in the USA Regulatory [Medical Devices] category. Mr. Heller was also named a “Leading FDA Lawyer” in 2005 by the Legal Times, which recognized him as an “intellectual powerhouse” and praised his significant knowledge of the law on medical devices and his specialty – “getting the green light from the FDA.” He was recognized by Washingtonian magazine in 2004, 2007, 2009, 2011, 2013 and 2015 as one of the top lawyers in Washington, D.C. in the area of food and drugs, selected as a “D.C. Super Lawyer” in 2007, 2008, 2009, 2010, 2011, 2012,  2013, 2014, 2015 and 2016, listed in The International Who’s Who Legal of Life Sciences Lawyers, and was also named a “Best Lawyer” in the Corporate Counsel Annual Guide to FDA LAW for 2010.

In The News

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在新闻中

Credentials

Anmeldeinformationen

专业资格

Education

J.D., 1973
University of Wisconsin-Madison
B.A., 1970
University of Wisconsin-Madison

(with honors)

Admissions

Bar

District of Columbia

Courts

U.S. Supreme Court
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