Drugs and Medical Devices

Call for Papers

• The basics of FDA law and regulations governing advertising and promotion, as well as sister agencies such as the Federal Trade Commission, which shares jurisdiction with FDA on certain regulated products (e.g., OTC drugs).
• The distinctions between labels, labeling and advertising and how that impacts FDA's powers, and
• How to properly position Direct-to-Consumer (DTC) promotions
• The Dos and Don'ts of promoting products on the internet, including social media sites such as Facebook and Twitter
• The perils of off-label promotion, including criminal and civil actions that have led to multi-billion dollar settlements by regulated drug companies
• Whether the First Amendment provides any insulation for truthful statements regarding regulated products;
• When disseminating medical educational materials crosses the line into improper promotion; and
• Key considerations on how to implement appropriate procedures and controls in your company to minimize the potential for regulatory action by the FDA or the FTC relative to promotion and advertising.