126 - If a product that has NOC (i.e., without conditions) but does have a black box warning, how prominent do the indication statement and black box warning need to be? We would like to include both in the fair balance section of the piece, but wonder if either text needs to be placed elsewhere in the piece as well.



  • Revised October 2019: Generally, the black box warning can appear with your fair balance block. Note that this warning must appear within a black box in the ad in order to reflect the PM. Also note that there are situations in which the warning is required to be repositioned. Consider, for example, a scenario in which the black box speaks to the importance of closely monitoring for drug interactions when the sponsor's drug is used in combination with Drug ABC. If the APS in this hypothetical scenario were to contain a claim depicting efficacy results for a protocol combining the sponsor's drug with drug ABC, we would require that the warning appear prominently on the same page as this claim. The indication must appear on the same spread as the first marketing message.


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