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PAAB Notice
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.
  • Fragments within a RTE

    PAAB Q&A rte
    2
    0 Votes
    2 Posts
    196 Views
    Jennifer CarrollJ
    Hi @cynthia-tab1, The following is provided with the understanding that the rep can only select one fragment per email in the example. In general, if the fragments are different messages, then they may not be reviewed under one submission as there will be discrete emails with distinct messages sent. Assuming the common content of the emails exceed 60% pickup, the emails should be submitted as a series for each separate fragment with an initial parent file and all subsequent fragments submitted as a child file. If the fragments are the same message but written in varying language, then an iterative submission may be possible under the same efile number. Please see our submissions guidance document under 2.2.1 (b) iterative submissions and (c) Other series for additional information.
  • Rep triggered email function disabled

    PAAB Q&A rte email rep triggered email
    2
    0 Votes
    2 Posts
    274 Views
    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.