Kellie Combs provides legal and strategic advice to pharmaceutical, biotechnology, medical device, food, and cosmetic manufacturers on a broad range of issues under the Food, Drug, and Cosmetic Act and the Public Health Service Act. Recognized as a “Rising Star” in Food and Drug Law by Super Lawyers, Kellie 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.
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