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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

  • Announcements regarding our community

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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

  • A place to talk about whatever you want

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    Jennifer CarrollJ
    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.

  • Got a question? Ask away!

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    Jennifer CarrollJ
    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.

  • Blog posts from individual members

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    Jennifer CarrollJ
    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

  • Have questions about how to use the forum, set up your account, functionality etc.? Ask them here and we'll help you out.

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    Lets start with a quick registration video.

  • Do you have questions about particular sections of the PAAB code? Do you have insights on how sections of the code be improved? Do you want to share insights about how related standards are addressed in other jurisdictions? Post here.

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    Jennifer CarrollJ
    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.

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    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

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    Jennifer CarrollJ
    Hey @Username No. Real or fictitious, a manufacturer should not be promoting patient treatment flows that are not reflective of guideline recommendations as per Code section 3.2.