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Hey @mimic909 This is a specific review question about specific pieces. It should be submitted for an opinion. You can request an opinion for exemption with a note that you’d like to proceed to review if not exempt, as per the PAAB Policy and Procedure for Reviewing Exemption Request eFiles. As general guiding principles, when you direct branded advertising to HCPs or branded patient information to patients through HCPs, it is subject to the PAAB Code and all other advertising regulations. This also applies to APS that promote a corporate service (e.g. co-payment) (s7.4). Payment to a site to include your brand in their space is “control” as the brand would not exist there without the sponsors interaction. While you may not control the copy in this space, it is still the manufacturers responsibility to ensure it meets advertising regulations.

Hey @NatBourre When images are presented they must be aligned with the indication. If they present an outcome, data to support this effect must be presented within the APS. A letter from medical/regulatory should be provided to confirm that the demonstrated effect in the image is aligned with/representative of the effect demonstrated in the trial (i.e. the average not the best-case scenario). It would not be acceptable to use the same images in both branded and unbranded advertising as when you link branded and unbranded, everything becomes branded. The images and their presentation in the unbranded pieces would have to be different.