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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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    Jennifer CarrollJ
    Hello @manufacturer @agency Process flow is a business decision. PAAB has adjusted its requirements for Medical/Regulatory sign-off to respect this fact. What's changing? PAAB will no longer require med/reg review to occur prior to initial PAAB submission. Upon submitting, if you have opted not to complete Medical/Regulatory review prior to PAAB review, please click "Not Yet" on the submission form. If Medical/Regulatory review was completed, you will continue to have the option to confirm this and provide the Manufacturer Medical/Regulatory contact. Click here to more about why, new form requirements, and what this means for the review process. Question? Post below and we'll get back to you. Thanks PAAB

  • A place to talk about whatever you want

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    Hi @Jennifer-Carroll Thank you!

  • 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 Afternoon @Manufacturer and @Agency It's crazy to say but we're now just past halfway through 2025! The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q2. See the Tag report here and the CEI report here. The Forum Quarterly Review for Q2 has also been posted here. If there's more you'd like to know in Q3, let us know in the comments below. Have a wonderful rest of the summer. 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.

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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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    The Advisory on Provincial Formulary Statements distinguishes 'reimbursement criteria' from 'definitions and notes'. Per the RAMQ Advisory, coverage claims must be accompanied by 'reimbursement criteria'. Can you please confirm if the 'definitions and notes' portion of the RAMQ listings are required to appear in APS? These usually deal with initial authorizations and continuing requests, and are not technically criteria.

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    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).

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    Thank you!