This course focuses on the regulation of food and drugs by the Food and Drug Administration (FDA). The course will examine the basic statutory framework and laws governing the regulation of drugs, medical devices, biologics, cosmetics, dietary supplements, and food, including the FDA's practices, procedures, and enforcement authority. This course will discuss the underlying policies guiding the substantive laws as well as their interaction with other areas of law, such as product liability, intellectual property, environmental regulations, and the medical profession. (Credits may be applied toward Transactional Law Practice concentration.)