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  4. 748 - Hello what kind of references are required to make a claim about number of patients treated with drug/device X worldwide? and about availability in x number of countries? Does Data on file suffice? if not what other references would be expected to approve this claim?

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748 - Hello what kind of references are required to make a claim about number of patients treated with drug/device X worldwide? and about availability in x number of countries? Does Data on file suffice? if not what other references would be expected to approve this claim?

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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Data on file would be acceptable for a claim about “# of patients treated with drug/device X worldwide”. Likewise, availability in X countries could be supported by data on file. Note that these claims should not be linked to or suggest safety or efficacy.

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    The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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