LAW 370 - Food and Drug Law

This course will examine the ways in which Congress, the Food and Drug Administration, and the courts have gone about regulating the medical products industries. We will highlight current issues which may include the FDA’s jurisdiction and enforcement authority concerning drugs, devices, biologics, and combination products; development, approval, advertising, and promotion of medical products; exclusivities for drugs and biologics and related competition issues; “orphan drugs;” and the relationship between federal regulation and state law. The course will be graded on the basis of in-class participation and a final examination.