An Introduction to Applicable FDA Offices, Essential Principles, & Key Definitions for Medical Product Advertising and Promotion

Discuss the relevant FDA offices that regulate advertising and promotional labeling of medical products, including drugs and medical devices for both human and veterinary use. Explore essential definitions and principles of medical product advertising and promotion.

Why it Matters

  • FDA Offices
  • FDA Enforcement
  • Key Definitions and Essential Principles of Advertising and Promotional Labeling
  • Types of Claims
  • Disease Awareness (Unbranded)
  • Traditional and Other Forums
  • Preapproval Communications
  • Submissions

Virginia Foley, Principal Consultant, Opus Regulatory, Inc.
Dolores M. Shank-Samiec, Executive Director, Office of Promotion and Advertising and Review, Merck & Co., Inc.

 

This session was recorded as part of FDLI’s Virtual Introduction to Advertising and Promotion for Medical Products Course in October 2020. 

 

 

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