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  3. Claims & Support/References for Claims

Claims & Support/References for Claims

243 Topics 404 Posts
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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  • Jennifer CarrollJ

    10 - What does "well-controlled and/or well-designed" in s. 3.1.1 mean?

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  • Jennifer CarrollJ

    4 - Why can't information from a study be used if the reference appears in the bibliography section of the Product Monograph?

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  • Jennifer CarrollJ

    2 - We are getting a new indication that was based solely on a very small open-label study with a subjective endpoint. The study was not mentioned at all in the PM, however, it was published.

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