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.
