She Will Represent Biopharmaceutical, Other FDA-Regulated Clients in Legal, Regulatory, Legislative and Public Policy Issues; Resident in Firm’s D.C Office
Deborah M. Shelton, who for two decades has represented companies in the biopharmaceutical, medical device, food, dietary supplement, and cosmetics sectors, has joined the law firm of McCarter & English, where she will lead the firm’s FDA regulatory practice.
Shelton will counsel a variety of companies, from start-ups to Fortune 500 companies, assisting them with the development and marketing of FDA-regulated products. She will assist clients in navigating the complex laws and regulations that govern FDA-regulated industries. In her practice, she will guide clients in all stages: business planning, product development, approvals, post-market compliance, life-cycle management, due diligence and contracting, litigation strategy, and legislative and regulatory policy advocacy.
Shelton’s diverse legal background – comprising significant external and corporate counsel roles – provides biopharmaceuticals clients with insights informed by a strategic, rigorous, and pragmatic approach. Shelton also has extensive experience with DEA administrative litigation and other compliance matters related to controlled substances.
Prior to joining McCarter & English, where she is a partner, Shelton was deputy general counsel for healthcare at Biotechnology Innovation Organization (BIO), the world’s largest biotech trade association. Earlier, she was senior regulatory counsel, and U.S. lead of the global regulatory policy team, for a Fortune 500 global biotech company. Prior to her corporate counsel roles, Shelton was a partner in the FDA regulatory group of the Washington, D.C., office of a global AmLaw 100 firm.
“An FDA lawyer with Deb’s intelligence, excellence, and experience represents immense value to our firm and clients,” said Michael P. Kelly, chairman of McCarter. “We’re growing by design firm-wide, with particular emphasis on smart growth in the nation’s capital and in practice areas that our clients, and the market in general, demand. Deb is the answer to all of that.”
Added Elizabeth Hanley, firm-wide leader of the firm’s intellectual property group: “Many of us have known Deb and worked with her for many years on FDA-related matters. Our clients have universally reported that she routinely helps solve their problems and maximize their opportunities – the very definition of a top attorney.”
Shelton is also an in-demand continuing legal instructor for sector-specific groups such as the Food and Drug Law Institute, and a frequent lecturer and writer on FDA-related topics. Shelton earned her law degree, with honors, from the University of Maryland School of Law. In her spare time, she serves as a patient advocate, and enjoys paddling her sea kayak and hiking with her rescue canine pals.