Expertise in all things FDA
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Expertise in all things FDA
Overview
Jeffrey N. Gibbs joined Hyman, Phelps & McNamara in 1990. Over the course of his career, he has developed an extensive knowledge of FDA law, including regulatory strategy, product approvals, advertising and promotion, appeals, citizen petitions, and enforcement actions. In recent years, Mr. Gibbs has focused primarily on advising medical device and IVD companies.
Based on his extensive experience working with the industry on FDA issues, and previously for FDA, he provides efficient, practical, timely and insightful guidance. He has worked with companies of all sizes, from global manufacturers to one-person start-ups.
Mr. Gibbs has written and lectured extensively on a variety of FDA topics, particularly the regulation of medical devices, IVDs, and enforcement matters. He was a member of the Editorial Advisory Board for the Food and Drug Law Journal from 1998 to 2004, serving as chair from 2003 to 2004. He was also a member of George Mason University’s Human Subjects Research Board from 2003 to 2011. He was a member of the Board of Directors of the Food and Drug Law Institute from 2009 to 2019, serving as both General Counsel and Chairman. He has received numerous recognition awards, including, “Life Sciences: Regulatory/Compliance – USA” Chambers and Partners Global (2021); Washington D.C. Super Lawyers (2021); “Who’s Who Legal: Life Sciences 2021”; “The Best Lawyers in America” (27th Edition-2021); “Who’s Who Legal: Life Sciences 2020”; Washington D.C. Super Lawyers (2020); LMG Life Science’s Star (2019); “The Best Lawyers in America” (26th Edition-2020); “Who’s Who Legal: Life Sciences 2019”; “The Best Lawyers in America” (25th Edition-2019); LMG Life Sciences Hall of Fame Award (2018); “Who’s Who Legal: Life Sciences 2018”; Chambers & Partners (2018); Washington D.C. Super Lawyers (2018); “The Best Lawyers in America” (24th Edition-2018); “Who’s Who Legal: Life Sciences 2017”; LMG Life Science’s Star (5th Edition-2016); “The Best Lawyers in America” (23rd Edition-2017); “Top FDA Lawyers,” Best Lawyers Supplement, The Washington Post (2016); Washington D.C. Super Lawyers (2016); “The Best Lawyers in America” (22st Edition-2016); Washington D.C. Super Lawyers (2015); LMG Life Science’s Star (4th Edition-2015); “Top FDA Lawyers,” Best Lawyers Supplement, The Washington Post (2015); “Who’s Who Legal: Life Sciences (2015); and “The Best Lawyers in America” (21st Edition-2015). Mr. Gibbs was co-editor and co-author of “European Lawyer Reference: Commercialisation of Health Care, Jurisdictional,” published by Thomson Reuters in 2013, 2015, and 2018, and “Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment,” published by the Food and Drug Law Institute in 2021.
Mr. Gibbs was Associate General Counsel for Enforcement at FDA, where he received an Award of Merit. He also was appointed Special Assistant U.S. Attorney for the District of Columbia, and, earlier in his career, clerked for a U.S. District Court Judge in New Jersey.