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akar

@akar
Agency
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

  • PAAB Exemption
    A akar

    @akar I would like to add a bit more clarity to my question - Are letters regarding product supply from a Medical Director considered PAAB exempt?

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

  • PAAB Exemption
    A akar

    Are letters from a Medical Director PAAB exempt?

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

  • PAAB exemption criteria
    A akar

    Does an email to HCPs mentioning brand name only to drive docs to order samples online require PAAB review, if no therapeutic class or indication are mentioned?

    Sampling

  • Generic product launch announcement: can we mention the original brand name?
    A akar

    Can a generic company make mention of the original brand name in their launch announcement communication to HCPs? We would like to explore two scenarios: one in which the original brand is no longer manufactured and our communication announces the launch of a generic so that docs can keep their patients on the same pill as the original molecule and a scenario in which the original brand is still available for purchase?

    Claims & Support/References for Claims
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