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Gregory H. Levine
Partner
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Greg Levine, co-chair of the Life Sciences Practice Group, focuses his practice on FDA regulation of pharmaceuticals, biotechnology and medical devices. He also counsels his pharmaceutical and medical device clients on compliance with health care fraud and abuse laws. Greg regularly represents clients before state and federal regulators on all phases of product life cycle and assists clients with both internal and government compliance investigations and enforcement actions.
Prior to joining Ropes & Gray, Greg was a partner at Arnold & Porter LLP. He is also a former legislative staff member in the U.S. House of Representatives, where he worked on FDA-related legislation, policy, and appropriations.
Pharmaceuticals/Biotechnology
- Assisted a pharmaceutical manufacturer in responding to an FDA Warning Letter alleging violations of Good Clinical Practice regulations.
- Assisted a pharmaceutical manufacturer negotiating, drafting, and implementing a Consent Decree of Permanent Injunction with FDA resulting from alleged violations of Good Manufacturing Practices.
- Counseled a pharmaceutical manufacturer on FDA labeling and promotional issues relating to the use of new clinical data.
Medical Devices
- Advised an in vitro diagnostic device manufacturer on 510(k) strategies.
- Co-led an assessment of a device manufacturer’s promotional practices.
- Assisted a device manufacturer in responding to an FDA Warning Letter alleging Quality System Regulation and Medical Device Reporting violations.
Health Care and Pharmaceutical Fraud, Abuse, and Compliance
- Led an internal investigation for a pharmaceutical client into a whistleblower complaint alleging violation of company anti-kickback statute guidelines.
- Drafted a compliance manual covering fraud and abuse, pricing, and FDA regulatory compliance for a manufacturer of specialty pharmaceuticals.
- Advised a biotechnology company on its educational grants policies.
Honors & Awards
- Chambers USA: America's Leading Lawyers for Business (2010-2011)
- The Best Lawyers in America (2011-2012)
- “Legal Elite in Corporate Life Sciences and FDA Regulation” Smart CEO (2011)
Professional & Civic Activities
- Editorial Advisory Board Member, BNA Medical Devices Law & Industry Report
©1996-2012 Ropes & Gray LLP. All rights reserved.
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Education
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JD, magna cum laude, Georgetown University Law Center, 1996
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AB, magna cum laude, Brown University, 1990
Bar Admissions
- District of Columbia, 1997
Memberships & Affiliations
- Food and Drug Law Institute
- Advanced Medical Technology Association (AdvaMed)
- Medical Device Manufacturers Association
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