Bio

Kellie Combs provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food and cosmetic manufacturers, as well as health care providers and academic institutions, on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. She is a partner in the life sciences regulatory and compliance group and is also a co-chair of the firm’s cross-practice digital health group. Kellie has extensive experience handling matters implicating FDA promotional rules and the First Amendment and also advises clients on FDA regulatory submissions, regulation of digital health tools, drug and biologic exclusivity, expedited development and approval programs, and post-approval compliance. In addition, she routinely conducts regulatory due diligence and negotiates key regulatory deal terms in connection with a wide variety of transactions involving drug, device, dietary supplement, cosmetic, and other consumer product manufacturers. She also regularly advises on administrative litigation and government enforcement matters involving FDA-regulated companies. Kellie is ranked as a leading lawyer in the pharmaceutical and medical products space by Chambers USA. Clients describe her as “incredibly responsive, measured and thoughtful” and note that she is “personable, responsible, reliable, and honest.” Kellie takes a practical, solutions-oriented approach to counseling clients and has wide-ranging experience advising legal and business leaders at the world’s leading life sciences companies, in addition to early-stage companies.