Good Morning @Constance
PAAB would need additional information to make the assessment of the claim proposed above. There are many considerations outside of just the source such as, does it suggest equivalence between products on a per unit basis and what is the intent of the per unit comparison. Given these unknowns, it is difficult to provide a definitive answer in a general space. We suggest submitting the copy for review.
AI Industry Working Group
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Prescription Pads/ToolsHey @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". -
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
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Pooled long-term extension dataGood Morning @HollyMed
Pooled data is not acceptable even if part of a pre-planned long-term extension study.
