Fundamentals of Healthcare Drug and Device Law

Catalog description

This course will teach students the fundamental legal, regulatory and ethical frameworks that govern the approval, regulation and marketing of pharmaceuticals and medical devices. Students will focus on the role of the US Food and Drug Administration (FDA) in approval and post-market process, intellectual property considerations and challenges, current litigation trends and case law, and policy challenges facing patients and industry. Students will also analyze the financial infrastructure impacting the development and delivery of drugs and devices in the United States including the history of coverage by federal, state and commercial health insurance. Students will gain a preliminary understanding of the complex interplay between law, regulation, healthcare delivery and healthcare innovation.