Use of actual patient images
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Would it be possible to include before and after patient images of a patient from a product's pivotal trial only in an APS? Or would data reflecting what the images are showing (e.g., skin clearance) be required to "quantify" the images?
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Would it be possible to include before and after patient images of a patient from a product's pivotal trial only in an APS? Or would data reflecting what the images are showing (e.g., skin clearance) be required to "quantify" the images?
Hey @laraholmes
All claims, whether implicit (e.g., conveyed through visuals) or explicit, must be supported within the piece. For "before and after" images, data must be provided to quantify the magnitude of the effect suggested by the visuals and should appear at or before the images. Additionally, the images must accurately reflect the data presented, rather than showcasing the best-case outcomes observed in the study.
