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Abyscat

@Abyscat
Manufacturer
PAAB Notice
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

  • Formulary message - exemption confirmation
    A Abyscat

    @jennifer-carroll Thanks! So, just to be clear, would the message "The formulary status for Drug XYZ has been updated" (not linked to product/therapeutic area messages) by exempt from PAAB review under s.1.5?

    PAAB Q&A

  • Formulary message - exemption confirmation
    A Abyscat

    @jennifer-carroll It is a fact that provincial formularies will often expand the funding criteria for listed products during a product's lifecycle. Can you suggest language that can be used to communicate this fact in a way that does not, in your words, amount to an "unclear claim of product merit and an embellishment". Note that AskPAAB Question 71 indicates that companies may inform of a changes in formulary status.

    PAAB Q&A

  • Formulary Claims
    A Abyscat

    According to the answer to Question 519 and other guidance PAAB has published, when an advertisement includes details relating to coverage (such as formulary codes or eligibility criteria), the presentation must be complete (e.g. inclusion criteria, exclusion criteria, definitions, notes, etc.) so as not be misleading. Can you advise how a company can meet this requirement for completeness when the coverage details for a drug may be viewed as broader than the terms of market authorization for that same drug?

    Claims & Support/References for Claims
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