This course examines the federal Food, Drug and Cosmetic Act. It will entail a detailed look at the law, policy statements, and literature related to approving new drugs and devices. The course covers such topics as human subjects research; product labeling and testing; OTC vs. prescription status; compassionate use exceptions; control of biotechnology techniques; differences between food, drugs and devices; and FDA enforcement. We will also explore how law and the legal system anticipate and also respond to changes in technology in ways that may enhance or inhibit the development of new technologies and new applications of old technologies. Attendance at classes is mandatory. Grade is based on final exam.
Prof. Katharine Van Tassel is the Interim Executive Director, Graduate Programs in Compliance and Risk Management and Visiting Professor of Law at Case Western Reserve School of Law. Her subject specialties are Health Law; Healthcare Finance; Food, Drug & Biotech Law; Public Health Law; Eldercare Law; and Governance, Compliance & Risk Management.
No textbook is required.