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  4. 475 - Can you describe the patient condition, consistent with the indication in your promotional material? As an example, the patient has suffered in silence many years before seeing the doctor, tried other treatments and is now seeking help. This example would be supported by authoritative sources. If not an option in promotional APS would it be possible in unbranded APS. Thank you.

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475 - Can you describe the patient condition, consistent with the indication in your promotional material? As an example, the patient has suffered in silence many years before seeing the doctor, tried other treatments and is now seeking help. This example would be supported by authoritative sources. If not an option in promotional APS would it be possible in unbranded APS. Thank you.

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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    You can provide authoritative information about the disease the patient has so long as you stay within the boundaries of the indication. With regards to describing particular patients (i.e. cases), please see Q&A 469.As an aside, I am uncertain how a message relating to individuals now seeking help would be constructive in the context of patient information as the patient, by definition, has already sought help and is either on therapy or about to embark on therapy. Calling out the failings of other medications would not be acceptable in branded or unbranded APS.

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    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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