Arent Fox Expands Food, Drug, Medical Device & Cosmetic Practice with Addition of Partner Deborah M. Shelton
With more than 20 years of legal and business experience, Ms. Shelton joins the firm’s Washington, DC office where she will continue to help clients navigate complex regulations for all FDA-regulated products, including a particular focus on drugs, biologics, digital therapeutics, and other medical devices.
“Deborah’s business and legal experience will be a great asset to our FDA and Life Sciences practices,” said Food, Drug, Medical Device & Cosmetic leader Brian P. Waldman. “She is a trusted advisor for companies that need to navigate complex regulations that impact business planning, product development, and approval.”
Prior to re-joining Arent Fox, Ms. Shelton led the Food & Drug practice at McCarter & English. Earlier in her career, she served as Deputy General Counsel for Healthcare at BIO, the world’s largest biotech trade association, and as lead US counsel to a multinational biotechnology company’s Global Regulatory Policy and Government Affairs teams.
Ms. Shelton frequently serves as the regulatory advisor in litigation involving FDA-regulated companies. Leveraging her extensive experience with Hatch-Waxman and regulatory exclusivities, Ms. Shelton works closely with her Intellectual Property colleagues on issues where patent and regulatory law intersect. She also partners with her corporate colleagues to provide FDA regulatory advice on due diligence and other transactional matters.
For Cannabis industry clients, Ms. Shelton analyzes federal laws, regulations, and legislative proposals. In addition, she provides strategic counseling and regulatory advice to companies seeking to enter the cannabis market and assists clients with responding to shifting legal and public policy issues at the federal level.
Arent Fox is a go-to firm for counsel at every stage of a product’s life cycle. The Food, Drug, Medical Device & Cosmetic team advises companies regulated by the FDA and trade associations in the food and drug space in all aspects of their business.