The FDA has just published its “Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014,” which includes these promised guidances under the “Advertising” category:
- Brief Summary and Adequate Information for Use: Disclosing Risk Information in Consumer- Directed Print Advertisements and Promotional Labeling for Prescription Drugs
- Considerations for Regulatory Submissions of Promotional Labeling and Advertising Materials including Submissions in Electronic Format
- Direct-to-Consumer Television Advertisements – FDAAA DTC Television Pre-review Program
- Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit
Information for Prescription Drugs and Medical Devices - Internet/Social Media Platforms: Correcting Independent-Third Party Misinformation About
Prescription Drugs and Medical Devices - Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical
Devices – Use of Links
You can find the AGENDA here.