LAWS 346 - Food and Drug Law
(3 cr.) This course explores both the historical background and current state of US 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.

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