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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.

Subcategories

  • Questions and comments around the Accelerated Review Options (set to launch in July 2022)

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    The new CEI Dashboard is now available in eFiles. This dashboard allows you to access all active survey invitations that are awaiting completion within your eFiles account. Once you have logged in to your eFiles account, you will see a new tab in the top navigation bar labelled “My surveys”. Within this tab is a list of your active survey invitations for any eFile where you have been identified as the CEI Contact. To complete the survey from this list, simply click the “Launch the survey” button associated with the eFile you wish to complete the survey for, and the survey will open within eFiles for completion. After completion, the survey will disappear from your list. If you abandon the survey before completing it, the survey will remain in your list until expiry so that you are able to complete it at a later time. Please note: Surveys will disappear from your list upon expiry. Survey invitations expire 2 weeks after initial invitation. If you would like to complete a survey for an eFile for which the link has expired, please contact review@paab.ca for assistance.

  • Questions and comments around the Accelerated Review Options (set to launch in July 2022)

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    @jennifer-carroll Thank you for clarifying these points. Highly appreciated.

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    Jennifer CarrollJ
    Hello @Manufacturer and @Agency PAAB is sending you off into the weekend with some more exciting news. Based on an assessment of the RWE/D submissions since launch of the RWE/D Guidance, PAAB has consulted with the RWE Expert Committee and revised it's approach to allow presentation of some single arm studies of previously treated patients. This revision adds flexibility and does not impact past approvals. If you'd like to learn more, please check out the PAAB Advisory - RWE: Single Arm Studies of Previously Treated Patients. If you have any questions, please post them below. Once again we'd like to thank the expert committee for working diligently to ensure that RWE/D presentations promote informed clinician decision-making while maintaining a long-standing tradition of truthful and trustworthy advertising.

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    @palanski We're so glad to hear your team is excited to use the new dashboard! We hope it makes tracking and resubmission more streamlined for everyone.

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    Jennifer CarrollJ
    Hi @georgian21 It is a requirement of the most recent Distinction Between Advertising and Other Activities document from Health Canada, that the sponsor is identified. This can be through the logo or copy. Pg 8: Section: Medical condition and treatment awareness materials “Declaration of sponsorship of such materials, by name or logo, is required and does not in itself render the material promotional.” When a DTC ad is reviewed by PAAB the inclusion of the logo is preferred but not mandatory. Our logo is intended to be an indicator to the audience that the APS has undergone an independent review to meet high standards that help support the health and safety of Canadians. In text only pieces (where the platform does not allow for images), we can consider the copy “Reviewed by PAAB”. These should be rare exceptions and can be discussed during the review process. HCP and patient APS require inclusion of PAAB logo (or text when the platform does not enable inclusion of logos)

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    Check out some of the top Digital Conference Myths we've seen to date.

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    Enter your Comments here.

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    Patrick MassadP
    What is this? PAAB has been asked to it make it easier to access stage 2 complaint rulings. This has been accomplished by maintaining a registry of all stage 2 rulings on a single webpage in a dynamic table. This complaints page can be accessed any of the following ways: By entering "complaints" in the website search field By clicking on the menu item "Complaints" found in the RESOURCE page. The RESOURCE page is accessible through the main navigation menu By clicking HERE We've subsequently been asked to consider adding any APS which are subject to future complaints to the registry. Prior to doing so, we would engage in formal consultation with several key stakeholders, including Health Canada and we'd report the consultation findings to our Board. However, before deciding whether to begin this consultation work, we'd like to get a rough idea of the size of the appetite for inclusion of APS within the complaint registry. Please let us know your thoughts by participating in this informal poll. Only users who are registered on the PAAB Forum can vote or to leave comments. Once registered, simply click on the bubble corresponding to your choice then click "Vote" to record your vote. If you see the results screen rather than the options, click “To Voting” to reveal the options. Reminder on how to register for an account Registration is easy, just complete this REGISTRATION FORM. Note that when setting the password, the system will look for at least 12 characters, at least one uppercase and one number. Will I need to register each time I want to participate in the PAAB forum? No. The account created by registering just once enables you to provide feedback AND ask questions in comment boxes throughout the website. It also enables you to receive email notifications when there is a reply to your post. Please note that some areas of the website are still under construction.

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    Enter your comments here.

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    Jennifer CarrollJ
    In order to create consistency across advertising pieces, and to reflect the rationale behind the “Reviewed by PAAB” logo design, the following ALT text copy should be used when descriptive copy is added for accessibility. Reviewed by PAAB The PAAB Logo Guidelines have been updated accordingly.

  • Questions and comments around the Accelerated Review Options (set to launch in July 2022)

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    @danthony Thank you for the clarification!
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    Current DTC Regulations

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    Jennifer CarrollJ
    Hello @tbalzarini Thank you for bringing this to our attention. We will update shortly. In the meantime, the Health Canada “Guidance on Distinction Between Advertising and Other Activities for Health Products” resource should be consulted.
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    PAAB Views July 2019

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    This topic is deleted!

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