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J

jen_kent

@jen_kent
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.
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Recent Best Controversial

  • Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context.
    J jen_kent

    Hi @Jennifer-Carroll,

    If we've already received full approval of our email template, but are now submitting a new APS (e.g., one-page PDF) that a client would like to be able to email out using that template, do we have to resubmit the template as a new file (even though nothing else has changed) or can we just include the what would be the "attachment name" in the new APS' submission cover letter?

    Similarly, if one of the files that we had specified in the email template is expiring, but is renewed/updated slightly, do we have to resubmit the email template, or just include mention that it "replaces efile 9XXXX in the email template (efile 10XXXX)" in the renewal's submission cover letter? (given that we always confirm that APS will only be disseminated within their approval periods anyways)

    Thanks very much in advance!

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