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Did you know? In celebration of PAAB’s 50th Anniversary, Messenger is now free of charge with all new and ongoing ARO submissions until March 31, 2026. Help reduce rounds of revision by communicating with your reviewer via messenger before resubmission. Learn more about Messenger here. [image: 1769440840904-messenger-is-free-of-charge-on-all-aro-submissions.png] @Manufacturer @Agency

To add another example, what about non-clinical claims about dosing like 'once-monthly'?

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.

Good Morning @Manufacturer and @Agency The PAAB Quarterly Tag and CEI Reports for 2025 have been updated to contain data for Q4. See the Tag report here and the CEI report here. This year is PAAB's 50th Anniversary! Stay tuned for treats throughout the year to celebrate this milestone. We're starting the celebration with: Client Messenger Service - Free with all ARO in Q1 to celebrate PAAB's 50th Anniversary Learn more here. Have a great weekend 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 there, Our regrets for the delay in responding. The answer to the above original question was provided in general terms based on PAAB code section 3.1.1 which states “…pooled data…are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable”. Even when the original trials are in the TMA, this does not confer acceptance for their pooled analysis in advertising. Q762 provided the general PAAB position as well but expanded to provide the narrow scope where PAAB has considered pooled data which is dependent on a multitude of factors. Q762 provided the starting point for consideration. As there are varying and specific factors that determine the acceptability of a pre-planned pooled analysis, it is beyond the scope of this forum to address. If there is a pre-planned pooled analysis where the study designs are identical or nearly identical, then we suggest consideration of our opinion service to determine if it may be acceptable for use in advertising.