John Manthei

John R. Manthei is a prominent partner at Latham & Watkins LLP, based in the Washington, D.C. office. He serves as the Global Chair of the Healthcare & Life Sciences Practice and also holds the position of Washington, D.C. Chair of this practice group.12 His legal practice is primarily focused on regulatory matters involving the U.S. Food and Drug Administration (FDA), particularly concerning the medical device, pharmaceutical, biotechnology, and dietary supplement industries.13

Manthei's expertise includes guiding clients through all aspects of the FDA-regulated product lifecycle. This encompasses pre-market development, FDA product submissions, market exclusivity strategies, and drafting international clinical trial agreements. He is also involved in FDA and Federal Trade Commission (FTC) regulation of marketing and promotion, quality system regulation, good manufacturing practices, FDA inspections, recalls, and compliance with export and import requirements.23

In addition to his regulatory practice, Manthei has extensive experience in Administrative Procedure Act litigation, having successfully challenged or defended FDA actions in several high-profile cases.3 Before joining Latham & Watkins, he served as Majority Counsel for the U.S. House of Representatives’ Committee on Energy and Commerce from 1998 to 2000.3 His work has earned him high rankings in Chambers USA and The Legal 500 US for his expertise in healthcare and life sciences law.23