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  4. 354 - What is the process to follow if I disagree with a reviewer's ruling and want to challenge it further?

Forum Update: Supporting Community-Led Discussion

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354 - What is the process to follow if I disagree with a reviewer's ruling and want to challenge it further?

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

    The "Submission guidance document" on the PAAB website outlines the escalation process. For your convenience, I have pasted the relevant segment below. The policy is intended to ensure that the reviewer has had a fair chance to resolve the matter and consult internally if necessary. Here is the excerpt: Escalation requests will be accepted only after having discussed a written review comment with the PAAB Reviewer, responding in writing and receiving a subsequent PAAB letter about the same issue. If you wish to escalate an issue regarding and eFile, please contact PAAB administrators with a detailed reason for the request, the eFile # and points to be discusses, and the requestors contact information. The administrator will forward the request to the appropriate PAAB personel.

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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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