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.
152 - As per question no.150, can we make a Quality of Life (QoL) claim based on a published peer reviewed study (condition/use on label) when there is no QoL data in the PM?
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The QOL data is not necessarily required to appear within the product monograph. The PAAB can consider a QOL claim based on a statistically significant improvement (versus an active or inactive comparator)observed in a published and peer-reviewed study which is blinded, randomized, controlled and designed a priori to measure this endpoint. The wording of the QOL claim should precisely reflect the endpoint which was measured. Also note that the indication will be considered in our assessment (e.g. some indications are limited to specific outcomes). Please call if you have any questions.
