Wednesday 7 January 2015

FDA's 2015 Guidance Agenda - Just Like the 2014 Agenda - Promises Publication of Guidance Regarding Use of Links to 3rd-Party Internet Sites

FDA/CDER has published its 2015 Guidance Agenda (here). Here's what's under the Advertising Category:
  • Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs
  • Direct-to-Consumer Television Advertisements – DTC Television Ad Pre-Dissemination Review Program for Human Drugs
  • Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
  • Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
  • Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products
  • Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs
Some of these guidances -- such as the DTC Television Ad Pre-Dissemination Review Program guidance -- have already been released as draft documents (see, for example, this review). I suppose the FDA is planning on publishing "final" guidance documents based on comments to the draft documents. Or maybe just "revised" draft documents.

I highlighted one item on the list having to do with "Internet/Social Media Advertising" -- Use of Links to Third-Party Sites. This was also on FDA's 2014 Guidance Calendar, but as we know no guidance was issued in 2014.

Perhaps none will be issued in 2015 either. Why not?

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