When should a vaccine be licensed, a drug approved, or an N95 mask authorized for sale? How do we assure the safety of produce grown in widely dispersed locations or of seafood harvested throughout the world? Should herbal supplements be regulated as food, drugs, or something in between? How aggressively, and in what manner, should the federal government regulate the cosmetics, tobacco, medical device, and human tissue industries?
This course examines the work of the primary federal agency responsible for these issues, the U.S. Food and Drug Administration. In addition to covering this substantive material, the course will introduce you to the process of understanding a complex statute, its implementing regulations, and related enforcement policies.