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Unauthorized Use of Content on this Site: 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 correspondence—are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content, or using it for model training or any related purposes, is strictly prohibited without the express prior written consent of PAAB. This includes, but is not limited to, the use of such materials in automated systems, machine learning models, or artificial intelligence applications.


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    Pivotal Trial Reprints on Branded Product Website

    CME, educational material, Reprints, reports, textbooks, independently created content reprints product website pivotal trial product monograph
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    Jennifer CarrollJ
    Hi @virginieb There are many considerations which would be assessed during the review process to determine whether this would be acceptable, but in general, the reprint of a PM study that is unedited and complete could be an acceptable downloadable resource on a gated HCP website. It should be disclosed where it will be placed and how it will appear (e.g. Study name? Description? Image?). This would be done as part of the review of the website to ensure that where it is placed for download is acceptable. Just one example of where it would not be acceptable: if the PM only included results of an interim analysis for an NOC/c product, we would question reprints of the final analysis even if they included the interim analysis results as NOC/c products are restricted to presentation of data from the PM only.