Results for LAW 458: Health Law: The FDA

(Same as LAW 458) Open to law and medical students; other graduate students by consent of instructor. The FDA's regulatory authority over drugs, biologics, medical devices, and dietary supplements. The nature of the pharmaceutical, biotech, medical device, and nutritional supplement industries.

This course will examine the Food and Drug Administration. It will focus largely on the FDA's regulation of drugs and biologics, but will also cover its regulation of medical devices, nutritional supplements, and, to some extent, its jurisdiction over special legal, social, and ethical issues arising from advances in the biosciences. Special Instructions: The class is open to all law or medical students. Graduate students may be admitted from other parts of the University by consent of the instructor. Substantial class attendance is required; in addition, the quality of class participation will play a small role in grading. Elements used in grading: Attendance, class participation, and final exam (In-school, open book). (Cross listed with Health Research and Policy (HRP 209)