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".
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Prescription Pads/Tools -
Assessment of Risk Management Tools (HCP/Patient)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.
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PAAB AI Regulatory Model - Opt-in deadline - Thursday
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 -
Pooled long-term extension dataGood Morning @HollyMed
Pooled data is not acceptable even if part of a pre-planned long-term extension study.
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Clarification on indication inclusion in multi-Product APSGood 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.
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Client Survey Report - 2024
What did we learn from you in 2024?In October, PAAB sent out our Client Survey to better understand your experience with us — what’s working, what’s not, and where we can grow together.
This year’s survey offered deeper insights into awareness of recent Code and guidance updates, and helped us identify how we can better support your PAAB experience moving forward.
Thank you to everyone who participated. Your feedback is already driving improvements across training, review practices, and communication.
Check out the full Customer Insights Report -
Adverse events rates that are not included in the PMHi @dmauri
This would not apply to comparative data. As per the first sentence “statistical analysis to support inclusion of comparative therapeutic data” is required. The comment also states that the AEs have to be aligned. Your original question appears to suggest that you are looking to speak to AEs which are not presented in the TMA and therefore would be difficult to demonstrate alignment.
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Adverse events rates that are not included in the PMHey @dmauri
Please see PAAB Q&A 427.
In summary, as per PAAB code section 5.9 and 5.7, when a side-by-side comparative presentation of out-of-TMA safety profile data is desired, a head-to-head RCT with demonstrated statistical analyses between the adverse events that are being compared should be provided as substantiation. In cases where such substantiation is not available, a comparative presentation would not be acceptable. Note that PAAB can consider a neutral comparative side-by-side AE presentation without statistical analysis or conclusion, if it exists in the TMA.
