AI Industry Working Group
Posts
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Change of company name/company legal -
Secondary Endpoint PresentationHello @Maha-Dogar
Thanks for your question. Please note that this topic has been addressed previously. Searching “secondary endpoints” in the forum should provide the relevant guidance. Note that the response applies regardless of whether or not the study appears in the TMA.
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Presenting recommendations for all drugs in class in a branded senseHey @kshulist
This question reads as tactic- and copy-specific and therefore would not be considered a general question. A general question would be something along the lines of: “In general, how should consensus guideline recommendations that apply to multiple products within a therapeutic class be handled when referenced in branded promotional materials?”
In response to such a general question, we would direct you to What Constitutes Current Medical Opinion?. Canadian guidelines may be used to support place-in-therapy claims relating to the sponsor’s product.
It is important to note that where guidelines reference a therapeutic class without specifically naming the sponsor’s product, presenting class-level claims in a branded context may be considered misleading. In scenarios where the sponsor’s product is not explicitly reflected in the guideline recommendations, we recommend discussing the proposed approach with your PAAB reviewer to explore potential options that could meet your objectives while ensuring the guidelines are represented accurately and in context.
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Scrollable fair balanceHey @Maryssa
The initial question related to self-directed digital advertising on an HCP website. The Q&A 199 language you referenced applies specifically to rep-directed materials and should not be relied upon for self-directed digital ads.
For self-directed digital ads, we suggest reviewing the principles presented in guidance on fair balance and web-link destination examples (search “study parameters”).
Required study parameters may be presented either within the same ad unit (including in a clearly labelled scrollable section immediately below the ad) or via a direct web-link destination, provided that:
• it is clear on the face of the ad where the study design is located,
• it is clear how to access the study design
• access does not require additional effort beyond a single click or scrolling (i.e. the content is accessed without any barriers)
Please note that where specific elements from the study parameters are required on the face of the ad (e.g., dose), those elements would not be acceptable solely as a web-link destination or scrollable section. -
Canadian product-branded website within the global .com domainHappy New Year @dmauri
This appears to be a specific question about a specific project and therefore would not qualify as a general question.
As a general answer to a general question, we would advise that you should consider linkage principles and assess if linking to unacceptable content is occurring. By having the Canadian page as a subdirectory of the US site it looks like a link is being created. If you’d like to have an interactive discussion, please consider PAAB’s new short-call service which is a 20-minute billable session over the phone or web-conference where the specifics of the project can be discussed, and additional guidance can be provided. Please reach out to review@paab.ca to discuss options. -
Updates to the RWE and Attention Icon Formatting and Expansion for Rare DiseaseDear @Manufacturer @Agency
To reflect feedback received from healthcare professionals (HCPs) and industry, PAAB is updating the RWE and Attention Icon Formatting Guidance.
The updated formatting standards were co-developed with communication agencies to ensure they meet both regulatory compliance requirements and client needs. This collaborative approach supports implementations that are not only compliant, but also effective in achieving advertising goals.
Additionally, through consultation with stakeholders and experts, PAAB is expanding our approach to advertising for rare diseases, to accommodate presentations from post-hoc studies. Learn more with the updated Attention Icon Guidance.
ATTENTION ICON FORMATTING
The RWE Guidance and Attention Icon Guidance came into effect February 1, 2024 and has allowed for Sponsors to present recent research findings to inform healthcare decision-making in a responsible manner which allows for the limitations of the evidence to be prominently disclosed. These updates are intended to clarify expectations and support consistent application of RWE formatting principles. The updated Guidance is now available on the PAAB website.
The revised approach is aligned with what was presented, discussed, and demonstrated during the PAAB National Workshops.
The updated RWE Formatting Guidance will apply to submissions moving forward. Sponsors are invited to update existing and future materials at their discretion, based on individual business decisions. There is no requirement to revise previously approved pieces (i.e. straight renewals) solely as a result of this formatting update. Any APS undergoing review currently may, but are not required to be updated based on the new formatting; however, all new files will be required to move to the new format effective at the start of Q2, 2026.
Further details and support will continue to be available through existing channels such as General Questions and PAAB Forum.
️ PAAB HOLIDAY HOURS ️
Just a friendly reminder that the PAAB office will close at 12:00pm on Wednesday, December 24th and will reopen at 9:00am on Friday, January 2nd. Please note that the period between closing and reopening is considered non-business time, and emails and phone calls will be returned as soon as possible once we resume operations.The PAAB staff wishes you a safe and happy holiday season, and we look forward to working with you in the New Year.
PAAB Admin
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Time and motion studyHey @Joleen-Santos
This would not qualify as a general question. Please see our website or reach out to info@paab.ca to explore billable options for consultation/written opinions and training.
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Scrollable fair balanceHey @Maryssa
Please see Banner ads, Q&A 199 and Linking mid-level FB to an attachment with high-level (in an email).
