MPE 610 Drug/Device Regulations

With the plethora of new communications vehicles, including direct-to­consumer advertising and the Internet, the goal of achieving marketing objectives and remaining in adherence with FDA regulations/guidelines has become increasingly difficult. This course will provided a working knowledge of the federal regulation of prescription drug promotion and associated marketing practices and will provide insight into drug promotion issues currently of interest to FDA and the pharmaceutical industry. The course will also consider the impact of products liability and anti-kickback concerns on developing marketing programs for prescription drugs.