Regulation of Medical Products

Catalog description

This course examines the U.S. Food and Drug Administration (FDA) interpretation and implementation of the federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA). FDA regulates food, drugs, animal drugs and feed, cosmetics, medical devices, tobacco products, and biological products (broadly speaking "food and drugs"). The course considers not only the substantive regulations and policies applicable to food and drugs, but also issues of administrative law (agency practice and procedure, as well as judicial review), enforcement authority (powers and priorities), the agency's place within our federal system, and the place of food and drug law in the larger legal environment. The scope of the class will vary from semester to semester, usually covering at least drugs and devices. Credit Hour : 1-3