(2 cr.) This course explores both the historical background and current state of the regulation of prescription brand-name and generic drugs, over-the-counter drugs, medical devices, biological products, and cosmetics, including the process for premarket approval of these products. The course covers the relevant provisions of the Federal Food, Drug and Cosmetic Act, as well as the Food and Drug Administration's authority to enforce the statute through administrative regulations and court enforcement. The relationships between FDA, Congress, and industry are explored and analyzed. Students consider the development and marketing of biosimilar products pursuant to the Biologics Price Competition and Innovation Act of 2009. Other topics include the regulation of advertising and promotional activities including off-label promotion, federal preemption in cases involving injury to patients from branded or generic drugs, FDA's inspection and enforcement procedures, and criminal liability for individuals and corporations. (May be offered for 2 or 3 credits dependent on instructor)


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