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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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    PAAB Q&A rte email rep triggered email
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    Jennifer CarrollJ
    Hi @nhem Change to copy post approval generally requires a new file and new fee. In the scenario described above, it sounds as though one option from the drop-down menu will be removed/de-activated. PAAB does not require that all options within the drop-down options list, remain active. If that is the intent of the revision and question, it would not require resubmission. However, addition of new content (e.g. replacing or adding options) that requires assessment post-approval requires a new file and new fee. If we have not fully captured the request, please reach out to admin to set up a call with the reviewer. It may be easier to assess the actions when looking at the file in question.