Provided by Kellie Combs
Kellie Combs provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food and cosmetic manufacturers, as well as hospitals 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 FDA regulatory practice group and is also a co-chair of the firm’s cross-practice Digital Health Initiative. Kellie is currently advising a number of clients on issues related to the COVID-19 pandemic, including the deployment of digital health and telemedicine tools, the manufacture and distribution of personal protective equipment, and the 3D printing of medical devices and components. She has extensive experience handling matters implicating FDA promotional rules and the First Amendment and also routinely advises clients on lifecycle management, regulation of clinical research, and post-approval compliance. In addition, Kellie conducts regulatory due diligence in connection with transactions involving drug, device, dietary supplement, cosmetic, and other consumer product manufacturers, and she has advised on a number of government investigations of FDA-regulated companies.
Kellie Combs is known for her strong regulatory focus within the pharmaceutical and medical products space. She is well versed in a range of FDA matters, including marketing and First Amendment issues.
"She's smart, thoughtful and offers great service." "Kellie is incredibly responsive, attentive to deadlines, provides actionable legal advice and incredibly knowledgeable on a range of issues."