LAW-2459 FDA Drug and Medical Device Regulation
This course examines the regulation of pharmaceuticals and medical devices in the United States by the Food and Drug Administration. This course will focus on the continually stringent and evolving regulatory environment, together with changing technologies and economic considerations under which pharmaceutical and medical device companies are consistently challenged. The course will also examine the differences between the FDA's approach to pre-market authorization of drugs, biologics, and devices and the necessary guidance to companies regarding their post-market reporting obligations. Classroom exercises give students multiple opportunities to analyze new information and explain how it applies to real-world situations. There will be a take-home final examination.