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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.
  • Request for research responders within a branded APS

    PAAB Code
    2
    0 Votes
    2 Posts
    493 Views
    Jennifer CarrollJ
    Hi @natbourre There is the ability to link to an unbranded survey questionnaire. However, as it is linked to a branded patient APS, the questionnaire would be subject to the PAAB code. As a reminder, linking unbranded to branded renders everything branded, so please be mindful that unbranded materials should not contain content which would not be accepted in a branded context. In addition, depending on the questions and if the answers/results are not intended for internal use only, the subsequent distribution of the results to patients or HCPs may be subject to advertising regulations as well.
  • consistent with TMA

    Claims & Support/References for Claims
    2
    0 Votes
    2 Posts
    578 Views
    Jennifer CarrollJ
    Hi @rlevit1 The PAAB does not have a single guidance document dedicated specifically to defining “consistent with the TMA”. While many of the principles of the CFL guidance can be considered analogous to PAAB requirements, we suggest referring to and applying only Canada-specific guidance, as ultimately this is the only guidance describing compliant advertising in Canada. Familiar principles such as scientific accuracy (Code Section 2.1), restriction to the approved use and population (s3.1), and appropriate communication of risk-benefit profile (s2.4) are all required by the PAAB code, among others; however, consistency with the TMA as a whole depends on the type of claim and/or evidence posited. Some resources describing consistency with the TMA relevant to certain contexts include: Guidance on Subgroup Analysis (https://www.paab.ca/resources/guidance-on-subgroup-analysis/) , Noninferiority Trials (https://www.paab.ca/resources/guidance-on-noninferiority-trials/), and Secondary Endpoints (https://www.paab.ca/resources/guidance-on-secondary-endpoints/) all describe consistency with the TMA specific to these analyses. Guidance on Real-World Evidence/Data (https://www.paab.ca/resources/guidance-on-real-world-evidencedata/). Section 1.1 describes consistency with the TMA with respect to Real-World Evidence/Data; points 1.1.1-1.1.4 can generally be applied to any randomized controlled trial. Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising (https://www.paab.ca/resources/guidance-regarding-duration-of-clinical-trials-used-as-reference-support-in-advertising/). Some principles in this guidance originate from the CFL guidance. Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc (https://www.paab.ca/resources/guidance_on_advertising_for_drugs_with_notice_of_compliance_with_conditions_nocc_feb_2018_typofix_docxpdf/), which precludes inclusion of any studies or data not found in the TMA.