Contact:
Jennifer R. Rupkey
414.225.8262
jrrupkey@michaelbest.com
Washington, D.C. (September 5, 2013) – Michael Best & Friedrich LLP is pleased to announce Seth A. Mailhot has joined the firm as a partner in the Transactional Practice Group and leader of the FDA regulatory practice effective September 3, 2013 in the firm’s Washington, D.C. office.
Prior to joining Michael Best, Mr. Mailhot worked for the U.S. Food and Drug Administration from 1994 to 2006 in a number of technical and regulatory positions. His experience at the agency includes work in medical device research, auditing manufacturing operations, radiation control programs and quality systems, and advising the U.S. Attorney’s Office with an investigation of criminal violations of the Federal Food, Drug and Cosmetic Act. Starting in private practice as an Associate with Latham & Watkins, LLP, Mr. Mailhot thereafter was Counsel and lead of the FDA Practice at Nixon Peabody, LLP, and was a Special Counsel with Sheppard Mullin Richter & Hampton, LLP in its Washington D.C. Office.
Mr. Mailhot has a broad and deep understanding of FDA’s regulatory scheme. He has experience with all products regulated by FDA, including pharmaceuticals, biologics, medical devices, tobacco, food, cosmetics, electronic products, and dietary supplements. His work for clients spans issues such as enforcement and recall matters, preparation and prosecution of FDA premarket submissions, product promotion and labeling issues, pharmaceutical exclusivity matters, and compliance with quality, regulatory, and manufacturing requirements.
Mr. Mailhot also brings great knowledge of the emerging field of telemedicine, advising numerous clients on software design control requirements of FDA, and compliance with Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act. His experience for clients includes FDA regulation of mobile medical apps and medical device cybersecurity.
Beyond working on matters directly involving FDA, Mr. Mailhot applies his regulatory knowledge to matters involving commercial transactions and intellectual property litigation. He has counseled numerous clients through the initial public offering process and has advised underwriters on financing FDA-regulated companies, as well as other transactions. Mr. Mailhot is often called upon to assist IP litigation teams with litigation involving FDA regulated products.
“We are thrilled Seth is joining us and helping to grow our D.C. office, as well as expand our service offerings. In addition to participating in our Transactional Practice Group, he will be an integral piece of our Agribusiness, Food & Beverage Group, as he brings a wealth of knowledge on FDA’s regulatory and enforcement processes and experience on USDA matters,” said Transactional Practice Group Chair, Michael S. Green. “His experience in bringing FDA-regulated products to market is also critical in our commitment to providing complete coverage for our Life Sciences clients. This is a welcomed addition to the firm as we continue to serve more clients in these fields.”
Mailhot received his B.S. from University of Massachusetts in 1994, and earned his J.D. as the Valedictorian in 2004, summa cum laude, from the New England School of Law.
