Scott Lassman is a partner in Goodwin’s Technology & Life Sciences Group. Mr. Lassman’s practice focuses on providing life cycle support to biotechnology, pharmaceutical and medical technology companies at all stages of development. He has extensive experience counseling senior management on navigating the FDA’s complex administrative processes and structure, including its dispute resolution and Citizen Petition processes, and has successfully obtained preliminary and permanent injunctive relief from the FDA in drug and device cases. He routinely provides strategic advice on product approval and lifecycle management issues, including the Hatch-Waxman Act and biosimilars law, and also advises clients on corporate, licensing and intellectual property issues.

Previously a partner at Kleinfeld, Kaplan & Becker, Mr. Lassman joined Goodwin in 2016.

Areas of Practice
Tätigkeitsfelder
业务范围

Experience

Erfahrung

工作经历

Professional Experience

Mr. Lassman previously served as Senior Assistant General Counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA), where he was responsible for FDA regulatory and policy matters. While at PhRMA, Mr. Lassman played a leading role in negotiating the Prescription Drug User Fee Act (PDUFA IV) with the FDA; enacting the Food and Drug Administration Amendments Act of 2007, and revising the PhRMA Code on Interactions with Healthcare Professionals.

Recognition

Mr. Lassman has been recognized in Best Lawyers in America, Administrative and FDA Law (2010-2018), Who’s Who Legal: The International Who’s Who of Life Sciences Lawyers (2008, 2014, 2015, 2016), SuperLawyers (2013-2016) and LMG Life Science Stars — FDA Pharmaceutical and FDA Medical Devices. In 2007, he received the PhRMA Board of Directors Exceptional Service Award.

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Credentials

Anmeldeinformationen

专业资格

Education

J.D., 1991
University of Virginia School of Law
(Order of the Coif)
M.A., 1988
University of Texas at Austin
B.A., 1985
Yale University
(cum laude)

Admissions

Bar

District of Columbia
Maryland
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Our clients rely on us for world-class advisory services, counsel on complex transactional work and high-stakes litigation. Specializing in matters involving the financial, life sciences, private equity, real estate, and technology industries, we use a collaborative, cross-disciplinary approach to resolve our clients’ most challenging issues. To find out more, please contact us.
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