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LAWS 655 - Food and Drug LawCredits: 3 Regulating products that account for approximately 25 cents of every consumer dollar expended in the United States annually, the Food and Drug Administration (FDA) is central to protecting and advancing the public health. FDA regulates food, drugs, biologics, medical devices, cosmetics, and tobacco products. This course will examine the federal regulation of products subject to FDA's jurisdiction, focusing on the regulation of human food, human drugs (prescription and OTC), biologics, and medical devices. It will examine the substantive law as well as FDA's enforcement power, practice, and procedure. This course will explore the historical development of food and drug law as well as contemporary issues, and examine the public policy considerations which have shaped the law. Basis of Grade: Examination and Class Participation Form of Grade: Letter |
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