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J

JDilly11

@JDilly11
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

  • Implications of updated safety information in Product Monograph
    J JDilly11

    Hello,

    The Product Monograph for a drug I work on is being updated. Specifically, there is adverse event information being added from a Dose Regimen study (which doesn't have a placebo arm). This data will be presented separately from the adverse event information from the placebo-controlled studies. My question is: what implications will this have for safety claims in promotional pieces? If we were to make a claim of "demonstrated safety profile", would we necessarily need to include the most common AEs from BOTH the placebo-controlled and Dose Regimen studies?

    Claims & Support/References for Claims

  • MOA Videos
    J JDilly11

    In a branded video highlighting a drug's mechanism of action, is it possible to also discuss mechanism of disease? If so, are there any limitations to keep in mind?

    Claims & Support/References for Claims

  • Middle level fair balance linking to high-level fair balance
    J JDilly11

    Hello, in the PAAB Document "Guidance on Base Fair Balance Level Selection and Placement (HCP Advertising", it mentions that "...on an electronic banner ad (on a gated site), middle level fair balance may direct the HCP to highest level through an electronic link." However, it also says that the highest level information must be within the same tool (or directly attached to it). Is it acceptable for middle-level fair balance in a banner ad to link directly to the high-level fair balance on the brand's HCP website? Thanks.

    Claims & Support/References for Claims

  • Unpublished extension data
    J JDilly11

    Hello,

    My client has extension data (not yet published) from one of their pivotal trials. The interim results from the pivotal trial are in the Product Monograph. They would like to use the extension data in promotional pieces, but is there any way to do this if the actual data hasn't been published yet? If the data is soon to be published, would a letter from the publisher confirming upcoming publication suffice?

    Claims & Support/References for Claims
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