Intellectual Property and Technology Law
718: Food and Drug Law
This course provides an overview of the Food and Drug Administration’s regulation of a variety of consumer products, including foods, dietary supplements, cosmetics, drugs, biologics, medical devices, and tobacco products. The course will examine regulation of these products through premarket research and development, clinical trials (where applicable), clearance and review, and post-marketing monitoring and reporting. Legal concepts of agency rulemaking, products liability, the Practice of Medicine doctrine, regulation of human subject research, state regulation and preemption, civil and criminal remedies, and enforcement mechanisms will also be explored.