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  4. 118 - Under what circumstances would it be acceptable to use a peer-reviewed, published study for a schedule F drug if that study uses a dosing regimen for the companion drug (always prescribed together but not subject of advertising, nor manufactured by the same company) that is inconsistent with the product monograph?

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118 - Under what circumstances would it be acceptable to use a peer-reviewed, published study for a schedule F drug if that study uses a dosing regimen for the companion drug (always prescribed together but not subject of advertising, nor manufactured by the same company) that is inconsistent with the product monograph?

Scheduled Pinned Locked Moved Claims & Support/References for Claims
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Advertising must be consistent with the sponsor product's Terms of Market Authorization as per Food and Drugs Act section 9.1 and PAAB code section 3.1. As such, products promoted for use in combination with the sponsor's drug should be within the sponsor's product monograph (PM). Additionally, the dosing of that combined drug should be consistent with the PM. Please call the PAAB office if you would like an opinion on your specific case.

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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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