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  4. 554 - On an HCP gated website that provides branded drug information, is it mandatory that the very first page after the gate is cleared be the "safety information" for that drug? Assuming the "safety information" link is accessible from the main navigation menu, can the landing page after the gate be some other content? Thanks.

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554 - On an HCP gated website that provides branded drug information, is it mandatory that the very first page after the gate is cleared be the "safety information" for that drug? Assuming the "safety information" link is accessible from the main navigation menu, can the landing page after the gate be some other content? Thanks.

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

    When assessing safety information or fair balance requirements, particular care is required for tools like websites as it is difficult to predict the path in which the information will be consumed. Additionally, the entire content is not typically consumed in one sitting. The simplest way to ensure physicians are exposed to the required fair balance copy is to include it on the brand product homepage. Linking middle level to highest level of fair balance on the homepage is an option which may help address space issues. Inclusion of a “Safety Information” menu item on every screen cannot replace the fair balance requirements described above. Please refer to the guidance document “Guidance on Base Fair Balance Level Selection and Placement” for more information.

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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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