For regulatory, legal, and marketing departments of medical product companies, complying with the requirements of Food and Drug Administration (FDA) and voluntary private sector codes has never been so complex.  New policies and guidances are being instituted, the number of enforcement actions and criminal investigations are increasing, court cases continue to be decided, and new methods of promotion are being introduced.  The consequences of failure to comply are significant:
enforcement actions, heavy fines, even criminal penalties.  

This annual event brings together the regulated industries and the regulators responsible for overseeing the advertising and promotion of prescription drugs, medical devices, biological products, and animal drugs. Representatives from all four of FDA’s medical product centers (CBER, CDER, CDRH, and CVM), the U.S. Department of Health and Human Services Office of the Inspector General, the U.S. Department of Justice Consumer Protection Branch, and the Federal Trade Commission provided you and your interdisciplinary promotional review team with the latest information on policy and enforcement activities, recommendations for approaching “gray areas” of advertising and promotion, and much more.  Industry experts explored best practices for promotional material reviews,
dissected recent court decisions and provided practical take-aways.

Department of Health and Human Services Office of the Inspector General, the U.S. Department of Justice Consumer Protection Branch, and the Federal Trade Commission provided you and your interdisciplinary promotional review team with the latest information on policy