DRUGS & DEVICES: LAW AND CURRENT ISSUES IN THE PRACTICE (HLTH7512)
2 credits. Lecture.

This course will cover the basic legal requirements for both prescription drugs and over the counter drugs as well as devices for marketability in US commerce. There will be discussion on the government bodies which have jurisdiction over these products and the enforcement tools they have to assure safe and efficacious drugs and devices in the US. We will cover some of the major current issues and cases which affect constitutional limits on the FDA regulations as it relates to 1st amendment rights and other compliance issues regarding advertising, constraints on distribution of new clinical trial results and methods which allow new data to reach the medical population.