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  PAAB Quarterly Forum Review - Q4/2025
  J Jennifer Carroll

  Happy New Year @Manufacturer and @Agency

  This year is PAAB's 50th Anniversary! Stay tuned for treats throughout the year to celebrate this milestone. We're starting with:

  ARO expansion + Client Messenger Service - Free with all ARO in Q1 to celebrate PAAB's 50th Anniversary Learn more here.

  The 2025 PAAB Q4 Forum Quarterly Review is now live!

  Some of the things that you might want to check out:

  • AI Assisted Submission Process - Call for volunteers
  • Attention Icon Update
  • Expansion for Rare Diseases
  • Creative Imagery Document Posted
  • Protecting the Integrity of PAAB Resources

  Coming in 2026: New service offerings, anonymous advertising reporting system and more...

  As always, thoughts and feedback are welcome below .
  Thank you
  PAAB

  Blogs

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  752 - Hi PAAB, I was reviewing my brands promotional pieces that will need to either be updated or be sent for rePAAB over the next few months. Since some of the pieces were approved, we have had a product monograph update. However, for certain pieces it does not change the Terms of Market Authorization and in some cases the copy in the piece wouldn't need to be changed. The only part of the piece which would need to be changed is the date of the Product Monograph (e.g. brochure) within the references. Since we have significant print inventory, is it permissible to have these submitted as a rePAAB to be valid for the next year until the next update or rePAAB without updating the date of the product monograph within the piece? Please advise. Many thanks.
  J Jennifer Carroll

  Hello @dmauri

  Yes, a fair balance sticker that replaces only the outdated fair balance with the updated version may be considered as a potential solution. The sticker must be limited to covering the existing fair balance only.
  Please note that if the sticker alters the original piece beyond the fair balance (e.g., obscures or impacts other copy or design elements), the material would be considered altered and would require re-PAAB review. This assessment can be made as part of the eFile submission for the sticker and would be communicated to the client at that time.

  Claims & Support/References for Claims

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  Why can't patient-directed information for prescription drugs be promotional?
  J Jennifer Carroll

  Hey @QnC

  Please see Q&A 352

  Patient Info

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  Change of company name/company legal
  J Jennifer Carroll

  Hello @ebailey

  A search of the term "company" on the forum will return Q&A 744 which should answer the above question.

  FYI post-approval change/preclearance exemption/what requires review/PAAB scope

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  Secondary Endpoint Presentation
  J Jennifer Carroll

  Hello @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.

  PAAB Code

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  Presenting recommendations for all drugs in class in a branded sense
  J Jennifer Carroll

  Hey @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.

  Claims & Support/References for Claims

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  Scrollable fair balance
  J Jennifer Carroll

  Hey @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.

  PAAB Q&A

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  Canadian product-branded website within the global .com domain
  J 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.

  Electronic Media

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  Updates to the RWE and Attention Icon Formatting and Expansion for Rare Disease
  J 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

  Announcements

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  Time and motion study
  J 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.

  PAAB Code