Branded Reprint Carrier for Pivotal Trial
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Would a branded reprint carrier for a pivotal trial included in the Product Monograph that only features the product name and logo (no claims or data) require PAAB review? Would the indication and fair balance be required? If so, which level of fair balance? Thank you
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Would a branded reprint carrier for a pivotal trial included in the Product Monograph that only features the product name and logo (no claims or data) require PAAB review? Would the indication and fair balance be required? If so, which level of fair balance? Thank you
Hello @jd
Given the scenario above, the reprint carrier would be subject to PAAB review as distribution of a reprint carrier qualifies as an advertising/promotions system (APS). The tool is likely subject to lowest level fair balance requirements.
