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  3. Claims & Support/References for Claims

Claims & Support/References for Claims

244 Topics 407 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

    12 - ACME Pharma ha 20% of the share in Rx's in its class and has been gained about 5% share over the previous year. NEWGUY Pharma has a 2% share, up from 1% the previous year. Can NEWGUY claim "fastest-growing" product within its class by virtue of a 100% growth? Even though ACME experienced only a 20%, twenty percent of a million is a lot more 100% of 20,000. How would PAAB rule NEWGUY's claim of "fastest-growing" or "largest annual growth"?

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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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