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AI MODEL - Phase I Testing Opt-In Deadline! @Manufacturer the Pharmaceutical Advertising Advisory Board (PAAB) is taking a significant step forward in innovation by launching the first phase of testing of our ground-breaking AI model on live files starting May 1st. On April 1st, in preparation for launch, we sent an eblast to industry announcing the deadline for full opt-in was now set for May 1st. Manufacturers who opt-in after the May 1st deadline will likely need to wait until a sufficient number of additional opt-ins are accumulated. This grouping of late opt-ins is intended to support cost-effectiveness. This initiative marks a major milestone in enhancing the efficiency, consistency, and effectiveness of advertising review processes for our industry. Ensuring that preclearance keeps pace with the speed and quantity of specialization afforded through AI adoption across the industry. If you have not yet reached out to PAAB and want to be among the first to experience the benefits of this exciting new project, please contact info@paab.ca today. @Agency we'll be reaching out shortly for your collaboration on the AI driven augmentation of the submission process. Cheers PAAAB

Good Morning @Supriya We assume that you are referring to a patient targeted APS. As a patient would not have a prescription for all the products, this would contravene the direct-to-consumer advertising (DTCA) regulations (Section C.01.044 of the Food and Drugs Act Regulations) to create a link to the therapeutic use (i.e. indication could not be included) for products they are not prescribed. While the three base levels of fair balance apply only to HCP-targeted APS, a weblink to the Terms of Market Authorization (TMA) links the therapeutic use, a violation of the DTCA regulations.

Hey @mhouzer The difference between the Standard 4-day initial review of RMTs and submitting as an ARO-4 is that the subsequent revision turnaround time will be an expedited 2-days rather than the standard 3-days. If you anticipate needing a few rounds of back and forth, this can be a good option to get to your final letter more quickly.

Good Morning @Manufacturer and @Agency Hope everyone is staying warm and enjoying the ️. The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q4. See the Tag report here and the CEI report here. The Forum Quarterly Review for Q4 has also been posted. These wrap up 2024! Thank you for another great year of collaboration and compliance. We hope to continue working with you in 2025 Thank you PAAB

Is patient consent information required to be clearly, visually separated from HCP information on a PSP form? I have seen examples of forms that have been approved where the only "visual separation" is that the patient information is in a separate box labelled "patient consent" but there is no different in colour, for example, versus the HCP information, whereas on other approved forms, the patient box is in a different colour than the HCP information. Would that be sufficient? I've also seen a comment that the patient should not be able to see the indication information on the form. Why would this be? The patient has obviously been prescribed the product if they are being enrolled in the program, so why would this be an issue?

Hey @GMC This copy would be reviewed in the context of the entirety of the piece. The context of the message “dispensed as written” will matter. See also the PAAB advisory on Advertising messages referring to "no sub".

Hello @tbalzarini Thank you for bringing this to our attention. We will update shortly. In the meantime, the Health Canada “Guidance on Distinction Between Advertising and Other Activities for Health Products” resource should be consulted.

Good Morning @HollyMed Pooled data is not acceptable even if part of a pre-planned long-term extension study.