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  4. 10 - What does "well-controlled and/or well-designed" in s. 3.1.1 mean?

Forum Update: Supporting Community-Led Discussion

The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.

Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:

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10 - What does "well-controlled and/or well-designed" in s. 3.1.1 mean?

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

    We generally ask for double-blind, randomized trials as reference support for advertising claims. They should be controlled by either placebo or an active comparator, and should be statistically analyzed. In the case of active comparators, it is important to note that the drugs must be compared under the same conditions of use (s. 5.2).

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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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