Kellie Combs

Practice Areas

Kellie Combs is the chair of the firm’s global life sciences regulatory and compliance practice group and a co-chair of the firm’s cross-practice digital health initiative. Kellie 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 has extensive experience handling matters implicating FDA promotional rules and the First Amendment and also advises clients on FDA regulatory strategy, 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, where she maintains a Band 1 ranking. 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. She also maintains an active pro bono practice, is a member of the firm’s Pro Bono Committee, and is a hiring partner at the firm.