COURSE DESCRIPTIONS

Food and Drug Law
Mr. Richard Alpert
2 credits day; 2 credits evening.

This course examines the regulation of food and drug products in the United States. These products include conventional foods, dietary supplements, prescription drugs, over-the-counter drugs, and medical devices. We will examine the Food, Drug and Cosmetic Act and FDA's regulatory approach, including the public policy choices behind the law - how and why these products are regulated. The course will focus on current issues such as protecting against unsafe foods; "front-of-package" nutritional and health claims; regulation of carcinogens and food additives; dietary supplement claims; approval of new drugs; orphan, investigational and generic drugs; and "off-label" promotion of drugs and medical devices.

Elective Course   Meets Health/Biomedical Concentration Requirements   Take Home Exam Required   LLM Course

<<Course Updated: March 14, 2012>>

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