Course Description

410.676 - Food And Drug Law

The Food, Drug, and Cosmetic Act (FD&C Act) governs the regulatory approval process for bringing a drug, biologic, medical device, food, or cosmetic to market. The class will discuss administrative procedures followed by the FDA. The course includes an overview of the drug, biologic, and medical device approval processes, and the regulation of food and dietary supplements. Students then will be exposed to the enforcement activities of the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the FD&C Act, as well as other statutes like the Public Health Service Act (which regulates the development and approval of biologics).