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  4. 539 - When submitting an APS for approval, can we submit the piece with the intent that it will be presented to HCPs in both a print format and a digital format as one submission? (Note - the content and layout of the piece will appear exactly the same in both modes of delivery).

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539 - When submitting an APS for approval, can we submit the piece with the intent that it will be presented to HCPs in both a print format and a digital format as one submission? (Note - the content and layout of the piece will appear exactly the same in both modes of delivery).

Scheduled Pinned Locked Moved Submission Requirements/process & Timelines/eFiles
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Often digital tools contain elements which are not available in print format. For example, linkages to other APS, the ability to swipe/tap/scroll, and other functional elements. If the digital format contains any additional functions beyond the print version then the piece would require separate PAAB review.

    If the same content/layout /flow is maintained in the digital and print version, and the APS context (e.g. branded vs. unbranded) and target audience remain unchanged, then the two pieces may be considered as part of a single submission. For example:

    • any size changes must be directly proportional throughout the APS
    • content on the page are not repositioned to optimize for landscape/portrait mode.
    • no new functionality is added other than zoom-in and zoom-out. ( i.e. PDF version of the printed piece is presented on a tablet).
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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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