Course Details

Regulation: Medicine & Health

This course examines issues in the regulation of drugs, medical devices, and biologics in the United States. With respect to drugs, it explores the process for pre-market approval of these products by the FDA, policy and constitutional issues in the marketing of these products to physicians and to consumers, the relationship between pioneer and generic drugs, the tension between federal regulation and state product liability law, and a variety of other issues. With respect to devices, it examines the various categories of devices, the pre-clearance process, preemption of state tort law, and other issues unique to devices. With respect to biologics, it covers current regulatory issues in the approval of these products and a variety of issues relating to regulation of blood, organ transplants, and vaccines. It will provide the legal background needed by such students to consider and understand the complex legal and policy issues raised by regulation of the manufacturing, promotion, and distribution of these products. Participation will count in the grading for this class; students will have a choice of a paper or in-class presentation for the final project. Prerequisite: Regulatory Strategy & Communication

Catalog Number: REGLAW 940-0


Course History

Spring 2018
Title: Regulation of Drugs, Devices & Biologics
Faculty: Bierig, Jack R
Section: 1     Credits: 1.0
Capacity: 45     Actual: 30

Spring 2017
Title: Regulation: Medicine & Health
Faculty: Wojcik, Jerzy
Section: 1     Credits: 1.0
Capacity: 20     Actual: 13

Spring 2016
Title: Regulation: Medicine & Health
Faculty: Braido, Joseph P
Wojcik, Jerzy
Section: 1     Credits: 1.0
Capacity: 24     Actual: 7