FDA Law

3 units

This survey course is designed to provide students with an introduction to the Food and Drug Administration (FDA)'s regulation of food, drugs, devices, and related products, which together comprise approximately 25% of the U.S. consumer economy. This course will also explore topics including but not limited to the scope of FDA's jurisdiction; the relationship between FDA, the executive branch as a whole, Congress, and the courts; how FDA interacts with non-governmental stakeholders; and how FDA addresses emerging technologies. This course will cover topics that are common to all of the product areas that FDA regulates as well as product-specific legal and policy questions, such as issues relating to protecting consumers against unsafe of mislabeled food, expediting approval of certain drug products, regulating complex new medical technologies, and other contemporary legal and policy topics. The course grade will be based primarily on a final examination. 3.0 units.