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 its jurisdiction over special legal, social, and ethical issues arising from advances in the biosciences. Special Instructions: The class is open to all law students; graduate or professional students from other parts of the University; and, with consent of the instructor, advanced undergraduates. 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).
3 units · Law Honors/Pass/Restrd Cr/Fail
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 its jurisdiction over special legal, social, and ethical issues arising from advances in the biosciences. Special Instructions: The class is open to all law students; graduate or professional students from other parts of the University; and, with consent of the instructor, advanced undergraduates. 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).