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  3. APS discussing diagnostic test
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APS discussing diagnostic test

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  • S Offline
    S Offline
    Supraja
    wrote on last edited by
    #1

    Hello PAAB,

    If a diagnostic test is required to determine eligibility for a drug, and we create a leave behind for HCPs explaining what the test is, how to order it, information on testing centres etc

    1. Either without mentioning the drug name at all, and not having any branding elements tying to the drug
    2. Or mentioning the drug name in a non-promotional, informational sense, also sans branding elements

    Would such a piece be PAAB-exempt in one or both scenarios? Thanks for your guidance!

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    • Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Good morning @supraja

      An unbranded leave behind outlining a diagnostic test that is not exclusive to drug treatment and is part of the natural course of diagnosis and is being used as a standalone piece, may be considered exempt if it is limited to diagnosis (i.e. does not make mention of treatment or suggest treatment as a result of the test). Detailing/distributing this piece with branded content would render it subject to review (linkage principles). In the context of a branded piece and/or “mentioning a drug name in a non-promotional” context, the piece would not be exempt.

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      • Jennifer CarrollJ Jennifer Carroll

        Good morning @supraja

        An unbranded leave behind outlining a diagnostic test that is not exclusive to drug treatment and is part of the natural course of diagnosis and is being used as a standalone piece, may be considered exempt if it is limited to diagnosis (i.e. does not make mention of treatment or suggest treatment as a result of the test). Detailing/distributing this piece with branded content would render it subject to review (linkage principles). In the context of a branded piece and/or “mentioning a drug name in a non-promotional” context, the piece would not be exempt.

        S Offline
        S Offline
        Supraja
        wrote on last edited by
        #3

        @jennifer-carroll Thanks very much, this is helpful!

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