LAW COURSE DESCRIPTIONS

LAW-2349 Pharmaceutical Law and Policy Prof. Marc A. Rodwin, 3 credits day; 3 credits evening.

This course focuses on pharmaceutical industry regulation and policy in the United States. It examines: the Food and Drug Administration process used to approve the sale of drugs; exclusive marketing arrangements; regulation of clinical trials to evaluate drug safety and effectiveness; regulation of drug marketing; prescribing drugs for off-label uses; financial and legal responsibility for drug induced injuries; post-marketing drug safety; drug firm financial relations with physicians and medical institutions; funding of research and development; pricing and access to drugs; the relation between U.S. and international drug markets and regulation.

Faculty comments : Grading based on a mid-term and end of semester exam and on class participation.

Elective Course

Meets Health/Biomedical Concentration Requirements

Take Home Exam Required

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