Curriculum Guide · Courses
Law and Regulation of Drugs, Biologics and Devices
J.D. Course 199 (cross-listed) | 3 credit hours
This course explores the legal, regulatory and policy issues that shape the research, development, and commercialization of drugs and biologics in the United States and Europe, with a particular emphasis on public policy issues. We will consider: the role of Federal, State and international regulation; regulatory and ethical issues in the development and testing of new therapies; managing incentives for innovation, including patent, regulatory and data exclusivity; tort liability and its function in the regulation of the pharmaceutical industry; pricing and payment systems and controls; and evolving medical technologies.
Recommended: Administrative Law.
Students may not receive credit for this course and Food and Drug Law or Food Law Seminar.