Advertising and Promotion Guidances

• Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs
• Consumer-Directed Broadcast Advertisements
• Direct-to-Consumer Television Advertisements -- FDAAA DTC Television Ad Pre-Dissemination Review Program
• CVM GFI #231 Distributor Labeling for New Animal Drugs
• Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices (PDF - 95KB)
• Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (PDF - 118KB)
• Industry-Supported Scientific and Educational Activites (PDF - 428KB)
• Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (PDF - 176KB)
• Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (PDF - 136KB)
• Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements
• Presenting Risk Information in Prescription Drug and Medical Device Promotion (PDF - 933KB)
• Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 115KB)
• Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (PDF - 103KB)
• Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF - 302KB)
• CVM GFI #240 Proprietary Names for New Animal Drugs