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SMurcar

@SMurcar
Agency
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 on conditions of proportional resize eligible for FYI
    S SMurcar

    I understand for resizes that are eligible for FYI's the scaling must be directly proportional and cannot result in a change to the layout/flow/content or functionality.

    Can you comment on if the following would be approvable as I believe it adheres to the above requirements. A small postcard, 5"x 5" is scaled up to 10"x 10". The scaled up pages are then arranged vertically (10" x 20"), matching the order of the PDF submitted to PAAB. This is printed on a poster board. No content is moved around on the pages themselves.

    Can you also comment on if adding a QR code next to the scaled up postcard, that links to a PDF of the postcard, could be approved as an FYI or would require that a submission?

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope fyi

  • Does switching in approved patient profiles constitute a minor update
    S SMurcar

    After reviewing the response to this question forum.paab.ca/topic/2723/aro-q-a-6-what-qualifies-for-a-minor-update I was wondering if the following scenario would qualify as a minor update. We have a detail aid that has a patient profile in it and we are in the process of creating a new stand-alone patient profile that we would like to include in the details aid once it is approved. If the content structure is the same in the new piece and this is the only change in the detail aid would this qualify?

    This is based on this excerpt "A minor update is a revision to an existing APS in which one of the existing presentations is updated with more recent information of the same type."

    PAAB Q&A

  • How to communicate transition to NOC from NOC/c
    S SMurcar

    If a product was previously approved with NOC/c and is expected to receive NOC after Health Canada has reviewed the completed phase 3 trial, can the new status of NOC be used as a sort of marekting benefit claim. Something similar to 'Product X now has NOC after completion of their pivotal trial', followed by an informative section on the difference between NOC/C and NOC? Could this also be something that is created as a sticker to go on existing materials overtop of the NOC/c disclaimer, or elsewhere on the piece.

    Claims & Support/References for Claims

  • How to handle an APS that includes exempt medical device messages and HCP messages that require PAAB review
    S SMurcar

    Based on previous replies regarding Class III medical devices we are aware that PAAB does not review pieces that are limited to the device itself and the advertising of such devices is governed by MedTech Canada (formerly MEDEC), however I am wondering if we wanted to include information about a medical device in an APS along with messages that PAAB has previosuly reviewed and approved would the new APS need to be submitted to PAAB if the new content is limited to advertising the device, which is outside PAAB's scope? Furthermore if PAAB would need to review this message, what type of support is requires for messages relating to device as they don't have a PM to reference, or would PAAB not require any reference?

    PAAB Q&A
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