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.
243 - If a product has multiple indications, but we are developing a promotional piece for just one of those indications, does the fair balance copy still have to contain all indications and balance copy for ALL the indications? Thank you.
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No. The piece need only contain the indications relating to the promoted uses. Note that some claims promote all indications (thus requiring presentation of all indications). An example that comes to mind is "Product X has 3 indications" (i.e. the 3 indication would appear in proximity to the claim). If the claims truly relate only to the one indication per your question, that is the only indication which is required to be presented.
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No. The piece need only contain the indications relating to the promoted uses. Note that some claims promote all indications (thus requiring presentation of all indications). An example that comes to mind is "Product X has 3 indications" (i.e. the 3 indication would appear in proximity to the claim). If the claims truly relate only to the one indication per your question, that is the only indication which is required to be presented.
@jennifer-carroll Hi Jennifer. Just a quick clarification on this response. If a product has multiple indications, but a warning & precaution is only specific to one of those indications, does that warning & precaution need to be incorporated to the fair balance of ALL indications or just when that particular indication is mentioned/promoted? Many thanks!
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@jennifer-carroll Hi Jennifer. Just a quick clarification on this response. If a product has multiple indications, but a warning & precaution is only specific to one of those indications, does that warning & precaution need to be incorporated to the fair balance of ALL indications or just when that particular indication is mentioned/promoted? Many thanks!
Hey @matt-s17
If the warning and precaution is clearly limited to one indication which is not presented in the piece, then no, it would not be required in a piece which did not have mention of that indication.
