Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the .. Read more regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena. What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing.

Highlights

• How to properly position Direct-to-Consumer (DTC) promotions
• Whether the First Amendment provides any insulation for truthful statements
• The distinctions between labels, labeling and advertising and how that impacts FDA's powers
• The basics of FDA law and regulations governing advertising and promotion
• The basics of FDA law and regulations governing advertising and promotion