Jeffrey N. Gibbs
Director, Hyman, Phelps & McNamara FDA Law Firm, United States
Lecture: Regulatory pathways to the US and European markets
US regulation of devices, their impact on commercialization, and tools for expediting entry into the US market. The course will help device companies better understand the multiple pathways to the US market, highlight difference between US and European regulatory systems, explain some of FDA's new approaches, e.g., benefit/risk analyses, Breakthrough Designations, and the de novo pathway, and teach how to maximize chances for successful, timely entry into that market.
Lecture: Risk-benefit analyses for maximizing chances of successful entry into markets
Jeffrey N. Gibbs is a Director in the Washington, D.C. law firm of Hyman, Phelps & McNamara, P.C. Before entering private practice, he was an Associate Chief Counsel for Enforcement at the Food and Drug Administration. Jeff also served as a Special Assistant United States Attorney in the District of Columbia in the Civil Division. He is currently Chairman of FDLI’s Board of Directors and was previously FDLI’s General Counsel.
Jeff has assisted in vitro diagnostic and medical device companies with a variety of regulatory issues, including FDA product approval, pre-submissions, regulatory strategy, product labeling, clinical studies, promotional and marketing programs, product appeals and enforcement actions. He received FDLI’s Distinguished Service and Leadership Award in 2013, and LMG Life Science’s Star Award in 2016. Jeff previously served on the Human Subjects Review Board of George Mason University, and has written and spoken extensively on a wide variety of FDA regulatory topics, and has taught medical device law at the University of Maryland and George Washington University.
Jeff graduated from Princeton University and New York University School of Law.