Husch Blackwell is pleased to announce that Seth Mailhot has joined its Washington, DC and Sacramento offices as partner and will lead the firm’s FDA practice for the Food & Agribusiness and Healthcare, Life Sciences & Education industry teams.
Mailhot has over 20 years of experience with all aspects of FDA regulation, both in private practice and in various capacities at the U.S. Food & Drug Administration (FDA). His practice is broad in its scope, ranging from assisting clients involved in FDA enforcement matters before the U.S. Department of Justice, to preparing and prosecuting premarket submissions to the FDA, and advising on corporate transactions involving FDA-regulated products and services.
Mailhot has practical experience with the full range of product types within the FDA’s regulatory purview, including food, medical devices, pharmaceuticals, biotechnology, tobacco products and radiation emitting electronic products. For food industry clients, he provides legal counsel in connection with human food, animal feed and dietary supplements and has deep experience with the dairy industry and ethanol producers.
Mailhot is experienced in the regulation of digital health software, including requirements for design controls and mobile medical apps. Mailhot’s drug regulatory practice involves counseling pharmaceutical manufacturers and distributors on pharmaceutical lifecycle management and Hatch-Waxman exclusivity and patent term extensions, compliance with over-the-counter monographs, and advice concerning good manufacturing practice requirements.
“FDA regulation is a core concern for many of our clients,” said Steve Carman, the head of Husch Blackwell’s Food & Agribusiness industry team. “Our clients will be very pleased with Seth’s ability to combine his training as a lawyer and chemical engineer with practical, real-world business acumen.”
Mailhot is a frequent author and presenter on topics relating to food and drug regulation. He also serves as a lecturer at Catholic University’s Columbus School of Law.