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.
126 - If a product that has NOC (i.e., without conditions) but does have a black box warning, how prominent do the indication statement and black box warning need to be? We would like to include both in the fair balance section of the piece, but wonder if either text needs to be placed elsewhere in the piece as well.
-
Revised October 2019: Generally, the black box warning can appear with your fair balance block. Note that this warning must appear within a black box in the ad in order to reflect the PM. Also note that there are situations in which the warning is required to be repositioned. Consider, for example, a scenario in which the black box speaks to the importance of closely monitoring for drug interactions when the sponsor's drug is used in combination with Drug ABC. If the APS in this hypothetical scenario were to contain a claim depicting efficacy results for a protocol combining the sponsor's drug with drug ABC, we would require that the warning appear prominently on the same page as this claim. The indication must appear on the same spread as the first marketing message.
