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T

TheAdpharm

@TheAdpharm
Agency
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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Recent Best Controversial

  • Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising
    T TheAdpharm

    @admin Can PAAB please clarify if it is one or both of these criteria for extension trials that need to be met in order for a reference to be accepted:

    Out-of-label studies evaluating a duration of use that is longer than the product’s pivotal trials for the corresponding condition
    Published, pre-planned extensions and subsequent interim and final analyses of randomized, controlled trials (RCTs)
    Additionally, should it be disclosed in the extension publication that:

    “These post-hoc analyses evaluated several endpoints related to response, complete response, and clinically relevant response. Of note, in these post-hoc analyses, statistical tests applied to these endpoints were not prespecified in the original study and may be considered hypothesis-generating in nature.”

    would the PAAB accept this publication as a reference to support advertising messages?

    Guidance on Code Application
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