Skip to content
Brand Logo

Forum
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

    3 3
    3 Topics
    3 Posts
    D
    Did you know? Manufacturer eFiles users have expanded permissions! In response to feedback received by manufacturers, we expanded permissions for manufacturer user and manufacturer admin user accounts in 2023. For all eFiles permissions, including client account permissions, please see PAAB : Resources : Do you know what your eFiles account can do for you?. If you regularly work within eFiles with a manufacturer user or manufacturer admin account, rest assured, nothing is changing in your day-to-day experience. If you currently do not have an eFiles account, we encourage you to register for greater transparency into the eFiles process. @Manufacturer

  • A place to talk about whatever you want

    5 12
    5 Topics
    12 Posts
    S
    Hi PAAB! Would a message like "X product is now back in stock!" be subjected to PAAB review? If it is not subjected to PAAB review, what are the conditions that it has to meet? Thanks in advance! Lily

  • Got a question? Ask away!

    1 2
    1 Topics
    2 Posts
    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

    0 0
    0 Topics
    0 Posts
    Jennifer CarrollJ
    Good Morning @Manufacturer and @Agency Hope everyone is staying warm and enjoying the ️. The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q4. See the Tag report here and the CEI report here. The Forum Quarterly Review for Q4 has also been posted. These wrap up 2024! Thank you for another great year of collaboration and compliance. We hope to continue working with you in 2025 Thank you PAAB

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

    3 3
    3 Topics
    3 Posts
    D
    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.

    81 189
    81 Topics
    189 Posts
    M
    Hi @Jennifer-Carroll , thank you so much for confirming!

  • 128 227
    128 Topics
    227 Posts
    Jennifer CarrollJ
    Hey @dmauri Great question. As long as the study publication does not contain information suggesting dosing practices inconsistent with Canadian labelling, the manufacturer’s Medical/Regulatory Affairs department can confirm that the dosing in the jurisdiction where the study was conducted is the same as it is in Canada. When it comes to “SoC”, per 1.7 of the Guidance on Real-World Evidence/Data, remember that pooled comparisons are not acceptable which would render the second half of the question moot. However, if you are referring to SoC in a single-arm study (per Advisory: RWE Single-Arm Studies of Previously Treated Patients), we would look to ensure that the overwhelming majority of patients were on a product available in Canada/indicated in the same population in Canada. Regarding "SoC", please note the guidance's remarks on representing the marketplace versus exclusions by design. An opinion can be a great mechanism to get specific guidance on an individual study as it allows for assessment of the study design, therapeutic area, and indicated product(s).

  • 1k 2k
    1k Topics
    2k Posts
    Jennifer CarrollJ
    Hey @JDilly11 Hard to provide comments without seeing the updated TMA copy. This question is likely better submitted as an opinion so that we can look at the update and the nature of the claims being made in current or proposed future pieces. As a general guiding principle, the assessment is made by looking at the update in combination with the APS copy to ensure it reflects the same context as the TMA. If there is something that would trigger the inclusion, then it will likely have to be added. Whether both data presentations are required will also depend on the APS copy and the finalized TMA copy.