Steven Tjoe is an associate in the firm’s Technology & Life Sciences group and a member of the firm’s FDA practice. He focuses his practice on product development strategies, regulatory compliance counseling, and risk analysis for offerings and transactions involving FDA-regulated entities. Mr. Tjoe specializes in analyzing premarket pathways, Hatch-Waxman patent and exclusivity issues, product adverse event risk profiles, product communications and marketing, and GMP compliance. Mr. Tjoe is admitted to practice in New York and Virginia only; his application to the D.C. bar is pending. He is working under the supervision of the partners at Goodwin.

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Mr. Tjoe is a member of the Food and Drug Law Institute.

Professional Experience

Prior to joining Goodwin, Mr. Tjoe served as a regulatory counsel in the FDA’s Center for Devices and Radiological Health, where he advised premarket review teams and senior management on regulatory issues arising from premarket review and classification, provided counsel and strategic advice on agency enforcement actions, and advised agency officials on issues related to the development and implementation of agency regulatory policies and regulations and the application of legislation, particularly in relation to in vitro diagnostics, laboratory developed tests, and the evolving field of precision medicine.

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Education

J.D., 2013
Antonin Scalia Law School, George Mason University
M.S., 2012
Case Western Reserve University
B.A., 2006
Duke University

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Bar

New York
Virginia
U.S. Patent and Trademark Office (USPTO)
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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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