Food and Drug Law (LAW-648-001)
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Roughly 20-25 cents out of every dollar spent by American consumers is for a product regulated by the U.S. Food and Drug Administration. The agency has jurisdiction over food, drugs, cosmetics, medical devices, biological products (including vaccines), animal food and drugs, and tobacco products, as well as some additional authorities. FDA regulation thus touches most products that fill the shelves of supermarkets and drug stores and virtually every product prescribed or used by the medical profession. Few other agencies regulate products or activities that play so intimate a role in daily life. Food and drug law is the law governing the actions taken by FDA to oversee the safety of this vast universe of products, to ensure that the labeling (and in some cases advertising) of products is accurate and reliable, and to shepherd safe and effective new medical products onto the market. This course provides both a general introduction to FDA regulation and a deep dive into the agency’s regulation of human food and human drugs.
Textbooks and Other Materials
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First Class Readings
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