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  4. 341 - If 2 Files are received that have conflicting Reviewer comments (one favourable, one unfavourable), what is the recommended process for progressing both Files in terms of consistency Should we progress the favourable review, then cite that approval for the unfavourable review? Bringing the inconsistency to the attention of the Reviewers tends to lean towards a conservative outcome from the PAAB.

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341 - If 2 Files are received that have conflicting Reviewer comments (one favourable, one unfavourable), what is the recommended process for progressing both Files in terms of consistency Should we progress the favourable review, then cite that approval for the unfavourable review? Bringing the inconsistency to the attention of the Reviewers tends to lean towards a conservative outcome from the PAAB.

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

    If the scenario outlined in your question occurs, the first course of action is to discuss the issue with the reviewer of record. After that discussion, you have an option to contact Senior Reviewer Preclearance Services to discuss whether the perceived inconsistency is an actual inconsistency and how to move forward. This allows you to get to a resolution more quickly, and it helps PAAB to address consistency issues. The PAAB reviewers write around 20,000 letters per year and historically real inconsistencies are few. The PAAB struck an industry member committee to investigate consistency during the review process and found that the PAAB has a systematic process to address inconsistency. The board will decide if an audit recommendation will be approved. Thanks, Ray.

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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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