This course describes the history of the FDA and CMS. Agency organization and responsibility is explained. Administrative practices and procedures are described, including formal and informal rulemaking. The course discusses the interaction of federal agencies with state regulators. It also discusses how to use regulation as a means to stimulate innovation. In this course, relationships between agencies and Congress, other agencies, providers and recipients of benefits are discussed. The course reviews how standards can be set through conditions of participation and the politics within the FDA and CMS.
Syllabus: The current course syllabus is available to enrolled students only.