Regulation of Drugs and Medical Devices

This seminar examines the Food and Drug Administration as an administrative agency combining law and science to regulate activities affecting public health and safety. The course will focus on testing and approval of pharmaceuticals and medical devices, including artificial intelligence. In some semesters at varying degrees, the course will also include food, nutritional supplements, tobacco, cosmetics, and/or veterinary products. A writing project involving research will be required. RECOMMENDED COURSES: Health Law Survey Colloquium; Administrative Law. UPPER-CLASS WRITING REQUIREMENT: This class may be used to satisfy the requirement. NOTE: Students who were enrolled in Food, Drug & Cosmetic Law (S) are restricted from registering.