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.
Use of real MRI scans in APS
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My client would like to work with KOLs to include real MRI scans for an APS. The scans would be of patients that fit in the product's indication. An agreement would be obtained to use the scans, yet we would use a fictional name for the patient. Are there any other considerations that we would need to consider from a PAAB perspective? Would we need a letter from the medical department to confirm that the scans fit the indication?
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My client would like to work with KOLs to include real MRI scans for an APS. The scans would be of patients that fit in the product's indication. An agreement would be obtained to use the scans, yet we would use a fictional name for the patient. Are there any other considerations that we would need to consider from a PAAB perspective? Would we need a letter from the medical department to confirm that the scans fit the indication?
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Hey @NatBourre
When images are presented they must be aligned with the indication. If they present an outcome, data to support this effect must be presented within the APS. A letter from medical/regulatory should be provided to confirm that the demonstrated effect in the image is aligned with/representative of the effect demonstrated in the trial (i.e. the average not the best-case scenario).
It would not be acceptable to use the same images in both branded and unbranded advertising as when you link branded and unbranded, everything becomes branded. The images and their presentation in the unbranded pieces would have to be different.