FDA's "Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics" has left many questions unanswered.
Proving deep interest in the topic, more than 400 people attended the "Green light or go slow: What FDA's new draft guidance means for social media in pharma" webcast on March 13, 2014 during which over 40 questions were asked.
This article focuses on a few of the issues, gray areas, and questions mentioned during this webcast and also in comments submitted to the FDA.
Items include (partial list)
Download the full text PDF file here:
- A Twitter Case Study
- Instruct Your Spokespeople!
- The Latent Spokesperson
- Scope of Control Over 3rd Party Sites
- Off-Label Adjacency
- Native Advertising