Jeffrey N. Gibbs

Director, Hyman, Phelps & McNamara

Over the course of his career Jeff Gibbs 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 LDT, IVD and medical device 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 long history of LDT regulation. Mr. Gibbs was previously an Associate General Counsel for Enforcement at FDA, where he received an Award of Merit.