I provide 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. I have extensive experience handling matters implicating FDA promotional rules and the First Amendment and also routinely advise clients on lifecycle management, regulation of clinical research, and post-approval compliance. In addition, I conduct regulatory due diligence in connection with transactions involving drug, device, dietary supplement, cosmetic, and other consumer product manufacturers, and I have advised on numerous government investigations and litigation matters involving FDA-regulated companies.