Introduction to the Regulation of Prescription Drug and Biologic Promotions

Promotional messages for prescription drugs are different from most commercial campaigns because the drugs, and the claims pharmaceutical companies make regarding their benefits, directly affect public health. The federal government regulates prescription drug and biologic promotions through organizations within the U.S. Food and Drug Administration (FDA). Topics in this course include: Regulation, Package Insert, General Requirements, Review Process, and Enforcement Actions. After completing this course, learners will be able to recognize how FDA defines promotional materials for prescription drugs and biologics. Learners will also be able to identify the organizations responsible for reviewing those materials as well as the general regulatory requirements with which promotional materials must comply.

After this course learners will be able to recognize how fda defines promotional materials for prescription drugs and biologics. recognize the organizations responsible for reviewing those materials. recognize the general regulatory requirements with which promotional materials must comply.