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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

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.

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.

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

Lets start with a quick registration video.

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.

Hello @Manufacturer @Agency In case you missed it, last week PAAB announced the expansion of eligibility for our Accelerated Review Options (AROs). 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. Historically, ARO was limited to a narrow slice of submission types. As of December 8, 2025 we have flipped the model: ARO is now available for most submissions, with only a few exceptions. [image: 1765309041625-table-for-forum.png] 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 NEW! 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

Hi @Jennifer-Carroll, I'm going to copy/paste 352 here for reference: @Jennifer-Carroll said in 352 - Can you please explain the rationale behind not being "promotional" in branded patient-directed material? Product claims would seem to promote adherence, and therefore be beneficial to the patient.: The PAAB code section you are alluding to is s6. This provision is intended to align with the federal advertising regulations for prescription products which only enable prescription drug advertising directed to HCPs and restricted consumer advertising (the latter being limited to name, price, and quantity). There are no enabling provisions for promotion to patients. Patient information must be consistent with part III of the product monograph (and this "information" is non-promotional). This information can support adherence by educating patients about how to use the product appropriately. However, the response doesn't quite touch upon my question. C.01.044 only prohibits advertising of prescription drugs to the general public. But patients are not considered part of the general public per the Distinction guidance document. Is this an oversight by HC, or can promotional advertising to patients really take place?