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S

Stanley

@Stanley
Agency
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

  • PAAB exemption for a pharmacy communication?
    S Stanley

    I'm looking into the PAAB code regarding what is/isn't PAAB exempt (s1.5), and I would just like to ask for some more clarification.

    s1.5.d states that contextual use of a healthcare product name can only be used in a context wherein it is not connected to therapeutic or promotional claims. s1.5.d then also gives examples of where this is permitted. However, is that an exhaustive list of examples?

    E.g., if I wanted to create a short piece just announcing the availability of a specific drug and nothing else, something like "X is back in stock", would that be PAAB exempt per s1.5.d? It seems similar to s1.5.d.iii, but it isn't the same.

    As a follow-up question, would the indication statement count as attaching the drug name to a therapeutic claim, thereby requiring PAAB approval?

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