The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:
- Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers
FDA's social science research has clearly been influencing recent guidances, so I assumed (and continue to assume) that FDA would want to update the risk presentation guidance in light of its most recent research about presenting risks, including the one-click study. Apparently, we'll have to keep waiting.
BTW, for those interested in the topic of biosimilar promotion, the Drug Information Association's Advertising & Promotion Regulatory Affairs Conference will have a session covering this topic. Full disclosure: I sit on the programming committee for the conference and will be leading the medical device primer the day before the full conference kicks off.