FDA Law & Policy

The Food & Drug Administration is charged with enforcing the laws and regulations surrounding the development, sale, and marketing of medical products, like drugs, devices, biologics, and supplements.These laws and regulations dramatically impact medical innovation, access to medical technologies, andconsumer safety. The goals of this course are twofold: (1) to provide students with a doctrinalunderstanding of selected topics in FDA law; and (2) to critically examine these laws and regulations to see whether they strike the right balance between competing values.