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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 737 - Hello, We would like to know if PAAB would accept the following tool: A desk-calendar for HCPs to use as a counselling tool for when they are scheduling the next dose of a vaccine. It would also feature facts about the disease and best practice tips. Thank you.
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737 - Hello, We would like to know if PAAB would accept the following tool: A desk-calendar for HCPs to use as a counselling tool for when they are scheduling the next dose of a vaccine. It would also feature facts about the disease and best practice tips. Thank you.

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

    Although the concept itself of creating a desk-calendar which can be used to council patients is possible, here are a few suggestions to try to ensure a smooth review process. First and foremost, this is HCP advertising and as such is subject to PAAB review. As the piece will be viewed by both HCPs and patients, it must be clear what information is intended for which audience. Finally, based on the question, it sounds like this will be a branded piece. Be cautious that the disease information does not go beyond the products TMA (i.e. it is on-label).

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