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

February 6 - February 7

What participants will learn:

  • 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 the FDA on certain regulated products (e.g., OTC drugs)
  • The distinctions between labels, labeling, and advertising and how that impacts the FDA’s powers
  • 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 “Commercial Speech” Doctrine provides any insulation for truthful statements regarding regulated products
  • When disseminating medical educational materials crosses the line into improper promotion
  • Key considerations on how to implement appropriate procedures and controls in participant company to minimize the potential for regulatory action by the FDA or the FTC relative to promotion and advertising
  • Enforcement Trends: FDA Hot Buttons (understating risk, overstating effectiveness), FTC, POM wonderful and substantiation, Private Litigation – Understanding Lanham Act and State Unfair Competition
  • Websites and Social Media: FDA Policies on the Internet
  • False Claims Act and Criminal Liability

Venue TBD

Email referral@complianceonline.com for questions


February 6
February 7