Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Branded Reprint Carrier for Pivotal Trial
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Would a branded reprint carrier for a pivotal trial included in the Product Monograph that only features the product name and logo (no claims or data) require PAAB review? Would the indication and fair balance be required? If so, which level of fair balance? Thank you
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Would a branded reprint carrier for a pivotal trial included in the Product Monograph that only features the product name and logo (no claims or data) require PAAB review? Would the indication and fair balance be required? If so, which level of fair balance? Thank you
Hello @jd
Given the scenario above, the reprint carrier would be subject to PAAB review as distribution of a reprint carrier qualifies as an advertising/promotions system (APS). The tool is likely subject to lowest level fair balance requirements.
