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Differential Diagnosis Tools for HCPs

Scheduled Pinned Locked Moved Claims & Support/References for Claims
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  • D Offline
    D Offline
    dmauri
    wrote on last edited by
    #1

    Hello! 2.4 of the Guidance on Branded Patient Information discusses how differential diagnosis information can be presented in a Branded Piece (even though such information would be discussing conditions for which the Product does not have an indication).

    Does this still hold true for branded HCP pieces? Or would this content only be permissible for HCPs in unbranded pieces?

    Jennifer CarrollJ 1 Reply Last reply
    0
    • D dmauri

      Hello! 2.4 of the Guidance on Branded Patient Information discusses how differential diagnosis information can be presented in a Branded Piece (even though such information would be discussing conditions for which the Product does not have an indication).

      Does this still hold true for branded HCP pieces? Or would this content only be permissible for HCPs in unbranded pieces?

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

      Hey @dmauri

      While it’s not an outright no, in the context of a branded HCP pieces a diagnosis should already have been made prior to consideration of the product. If a piece with differential diagnosis was to be considered, it would have to be overtly clear that it was to ensure the proper patient selection and there was no inference of off-label use.

      Ref: Guidance on Branded Patient Information
      7a4ab826-500b-4071-b0a0-9aa991f83f73-image.png

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