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.
Fair Balance
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Question: It is our understanding that an APS that only contains dosing information (i.e., a standard dose card with no messages of efficacy or safety) would typically require low level fair balance (as per the Guidance on Base Fair Balance Level Selection and Placement in HCP advertising). However, if an APS contains information relating to dose modifications due to safety concerns, would that change the fair balance requirement from low to middle? (even though the dose modifications section is within the DOSAGE AND ADMISTRATION section of the PM). Dosage modifications seems to be inherently a ‘safety’ concern – and we question whether this would prompt a higher level of fair balance.
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Question: It is our understanding that an APS that only contains dosing information (i.e., a standard dose card with no messages of efficacy or safety) would typically require low level fair balance (as per the Guidance on Base Fair Balance Level Selection and Placement in HCP advertising). However, if an APS contains information relating to dose modifications due to safety concerns, would that change the fair balance requirement from low to middle? (even though the dose modifications section is within the DOSAGE AND ADMISTRATION section of the PM). Dosage modifications seems to be inherently a ‘safety’ concern – and we question whether this would prompt a higher level of fair balance.
Hey @tmcm
The nature of the dosing modifications and the manner in which they are presented, will impact the level of fair balance. A dosing tool with cautionary dosing modifications may be subject to the lowest level fair balance. If the modifications are positioned as a product benefit it will likely require highest level fair balance.
