(3 cr.) This course explores both the historical background and current state of U.S. Food and Drug law, including the foundation and evolution of the Food and Drug Administration (FDA) the pre-market approval processes for branded and generic drugs, biologics, and medical devices, as well as regulation of post-marketing promotion, manufacturing, distribution, and safety surveillance of prescription-only products; regulation of cosmetics, food, dietary supplements, and food additives; FDA inspection and enforcement procedures; federal preemption and tort liability.

Sessions

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