As a follow up to question 593, if we want to point to European guidelines as there are no Canadian guidelines and the US guidelines are many years out-of-date and don't include new drug classes, does the letter need to be from a recognized national Canadian health professional organization representing this therapeutic area? Or could it be a provincial organization, for example the Quebec professional organization?
J
Jennifer_CM
@Jennifer_CM
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Posts
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Does the recognized Canadian health professional organization have to be a national organization? -
Qualified Treatment Centres in APSWe would like to create a rep email that directs referring physician to the qualified treatment centre (QTC) in their region for a specific therapy. Does PAAB require a DOF or another reference about the name of these centres? Could the list include ones that are in the process of approval as a QTC but not yet approved to avoid having to update the APS as each one comes aboard? The manufacturer would not select any QTC for the email until it is approved.
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Patient materials for orginator therapy and biosimilar@jennifer-carroll Would the same apply if both therapies are from the same company? Could we reference both part III sections of the TMAs if the wording was the same?
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Patient materials for orginator therapy and biosimilarWe're creating patient materials about an originator therapy and its biosimilar. If I refer to the therapy throughout the APS by its non-proprietary name, could we also include the different brand names in parentheses at first mention of the product? Or can we only include the non-proprietary name throughout the piece?
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Defining "data gathering is complete" for trials -
Defining "data gathering is complete" for trials@jennifer-carroll Can you point me to section 8 of the code as I could not find it on the website or when I downloaded the "flattened" version of the code.
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Defining "data gathering is complete" for trialsAs a follow up to question [223], if an ongoing study has a primary endpoint completion in November 2023, an interim data read out in January 2024 and is planned to fully complete in 2025, when do we have to stop discussing the trial? Is it in January at the read out as the study is not fully complete to 2025? Or is it at the primary endpoint completion?