HLTH 607 Pharmaceutical Compliance

Academic Year

This one credit course will expose students to the regulatory requirements of the Food and Drug Administration and fraud and abuse laws as they pertain to pharmaceutical and medical device companies. With the use of real-world examples, students will explore issues related to advertising, labeling, and promotion of drugs, off-label use and limitations, direct to consumer marketing, the Sunshine Act, and regulatory restrictions on sales and marketing. Students will also learn the elements of an effective compliance program as it pertains to these issues.