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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 43 - I am interested in producing an empty folder with my product name and logo on the front, PI on the back. The folder is to be provided to representatives with no contents. Reps would have a choice of any currently valid and PAAB approved contents to place inside, the whole package to be left with the physician. When I submit the folder to the PAAB for review, is it sufficient to explain that the only possible contents will be valid and PAAB approved APS, or is it necessary that I submit with all the possible combinations and permutations of contents? Am I permitted to submit for review a reprint which I would also like to be available for inclusion?
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.

43 - I am interested in producing an empty folder with my product name and logo on the front, PI on the back. The folder is to be provided to representatives with no contents. Reps would have a choice of any currently valid and PAAB approved contents to place inside, the whole package to be left with the physician. When I submit the folder to the PAAB for review, is it sufficient to explain that the only possible contents will be valid and PAAB approved APS, or is it necessary that I submit with all the possible combinations and permutations of contents? Am I permitted to submit for review a reprint which I would also like to be available for inclusion?

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Declaring that you will only include valid PAAB approved material should be sufficient. Keep in mind that you may be restricted from including Editorial material in a product branded folder even though it was PAAB approved. The PAAB does not require submission of independently published reprints; however if you sent it to us we would tell you if it was acceptable advertising in relation to other requirements of the PAAB code.

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