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Jennifer Carroll

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.

Jennifer Carroll

Happy 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.

Jennifer Carroll

Dear @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

Jennifer Carroll

Hey @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.

Jennifer Carroll

Hey @Maryssa

Please see Banner ads, Q&A 199 and Linking mid-level FB to an attachment with high-level (in an email).

Jennifer Carroll

Happy Monday @charlton

No. This would not be an acceptable comparison. See Q&A 674 and Can we present a side-by-side comparison of the trial design of our product's pivotal trial vs. the trial design of our competitor?.

Jennifer Carroll

Hello @Maryssa

Q&A 501 is exactly the one we would have pointed to @dmauri . However, the copy "Now authorized" alone is incomplete (authorized how? for what?) it should be restricted to "Authorized for use in..." or "Authorized for sale in ...".

Jennifer Carroll

Happy Monday @Manufacturer @Agency

Change is in the air for PAAB’s Accelerated Review Options (AROs)!

A client favourite, the ARO service has built a strong track record of expediting approval for the types of submissions that fall within its scope. This success has motivated us to explore creative ways to expand its availability, and make it even better.

This expansion is designed to meet industry needs head-on. We’ve listened to your feedback and invested in processes that make this possible.

The following outlines the key changes to the ARO service including a revised fee structure that will take effect December 8th, 2025.

New: ARO availability broadened significantly

Historically, ARO was limited to a narrow slice of submission types. As of December 8, 2025 we are flipping the model: ARO is now available for most submissions, with only a few exceptions.

Note: Previously approved content (appropriately shaded) is not considered new content and would not apply to the new content page limits listed above.

If you'd like your APS assessed for ARO eligibility due to special circumstances (e.g., PAAB has already provided an opinion on the acceptability of a study), please reach out to review@paab.ca for a free assessment

Messenger functionality is now included with every ARO until March 31, 2026 at no cost

We’ve received very positive feedback on the new messenger feature, and early trends show that it effectively contracts time to approval. In advance of our 50th anniversary, we are offering messenger bundled with any ARO review at no additional cost for the end of Q1, 2026.

To activate messenger, either request it within your initial submission form or email review@paab.ca. This applies to both ongoing and new AROs. Please note that only one package of 5 messages is included as part of this offer.

Note: Messenger remains available at cost for standard (non-ARO) submissions.

ARO is now available for DTC submissions

ARO-2 can now be used for direct-to-consumer (DTC) submissions, provided the submission contains fewer than 10 pages of new content. There are no exclusions applicable to ARO-4.

Notable ARO fee changes

• ARO supplemental page fee increase to reflect the more detailed assessments that are now available to ARO:

ARO-7 and ARO-10: $2/page → $4/page
ARO-2 and ARO-4: $4/page → $8/page

• Removal of automatic upgrades for short ARO submissions: Previously, APS with ≤2 pages of new content received a free level upgrade. This policy created tracking and reporting challenges. Broader ARO availability would further accentuate these challenges. As such, automatic upgrades have been retired.

Please reach out below with any questions.
Thank you
PAAB Team

Jennifer Carroll

Hello @support
If we are to assume that this is in an HCP gated space, we would advise that claims should not directly/indirectly highlight things like the shortage of competitor(s). Instead, the message may focus on reminding the audience about the sponsor’s product and availability in the market. You correctly identified that it would not be exempt. The piece would be subject to the Code and would require lowest level fair balance if restricted to a product availability message.