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.
Outdated indication
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Suppose a product has an outdated indication (15+ years old), where the name of the disease itself has been superseded by new terminology and more current medical practice.
Apart from going through a TMA update, is there any documentation or justification a Sponsor could provide to PAAB, in order to accept inclusion of new studies based on the newer disease terminology?
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This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”.
Let’s look at a few examples of where it would not be acceptable.
- If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA.
- If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”.
- The studies based on “newer disease terminology” result in the patient populations or outcomes being broader than those outlined in the Product Monograph.
If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)
