LAW 718 - 001

This course provides an overview of the regulation of a variety of health care and medical products overseen by the Food & Drug Administration, including foods, dietary supplements, pharmaceuticals, medical devices, and tobacco products. The course will explore topics regarding premarket research and development, clinical trials, review and approval, and post-marketing monitoring and reporting. Legal concepts of agency rulemaking, products liability, commercial free speech, human subjects research, state regulation and preemption, civil and criminal remedies, and enforcement mechanisms will also be explored. A science background is not required for this course.