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• About

  Want to know more about the organization, strategic plan, services, and fee schedule? Ask here.

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  @NatBourre You can see the link to the community guidelines in the top right corner of the forum or it will be a link available on all pages of the updated PAAB website.

• Announcements

  Announcements regarding our community

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  Hello @manufacturer @agency

  The PAAB is excited to reveal our plan to launch a new service that’s intended to reduce the time for submission approvals.

  With a view to launch a pilot later in the year, the Accelerated Preclearance Pathway (APP) will complement the existing preclearance pathway currently in place.

  At this early stage, we’d like to invite you to comment on the proposed new service via the link below. Here, you’ll be able to learn more about the service and provide feedback.

  Please check out www.paabfeedback.ca to learn more and for the opportunity to comment. Commenting will close on April the 14th, so do not delay in providing your feedback.

  Please feel free to post any questions in the comments below.

• Tours

  A place for patient and healthcare professional feedback.

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  Enter your comments here.

• PAAB Forum Tutorials

  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.

• Newsletters/Blogs

  Blog posts from individual members

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  Good Afternoon @aboucouvalas

  It’s important to note that the naming convention mentioned above is to allow for pieces to be attached to a standardized email template and therefore will not have the indication and appropriate level of fair balance associated with it. If you wish to send an email with three different patient information tools for one brand across three indications, it may be worth considering a branded email. At this point, the email could contain the appropriate level of fair balance and allow for the identification of the therapeutic area within the naming convention. Note that should you take this route, the name of all attached tools should be included in the email submission.

• PAAB Code

  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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  Hello @tmcd

  As per the document Tips on Claims Relating to Patient Assistance Programs,:
  “Observational data on retention could be considered if the program has a valid and reliable mechanism to monitor when prescriptions are filled. Sufficient information about the program must be provided to enable PAAB to make this assessment. The APS claim/data from a manufacturer’s patient support programs should be non-comparative (as it relates to the manufacturer’s product), it should reflect past study findings (i.e. formatted in the past-tense), and it should be structured so as to limit the findings to the support program. Study parameters such as the time period pertaining to the claim/data could be relegated to a footnote. Note that retention data will be required to be updated every 6 months as changes in the market place can impact retention.”

• Events & Training

  Have more questions about training? Let us know.

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• Resources

  Guidance on Code Application

  Guidance on Submission Procedures

  Guidance on DTCA / DTCI Regulations

  Newsletters

  PAAB Icons

  Activities

  External Resources

  PAAB Logo
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  Hello @healthymind

  By October 1, 2021, the vast majority of APS in the market place will bear the new logo. Although this date will mark the end of our 1-year transition period, it is understood that straight renewals (pieces with absolutely no changes) bearing the old logo will continue to be disseminated / distributed until stock is depleted. Our expectation is that, upon reprinting, the logo change will be implemented. With the understanding that the updated logo will adhere to our style guide, this change does not trigger a need for resubmission. To be clear, at no point are manufacturers expected to destroy old stock on account of the logo change.

• PAAB Q&A

  Claims & Support/References for Claims

  Non-product branded APS, pre-NOC teasers

  NHP, OTC

  CME, educational material, Reprints, reports, textbooks, independently created content

  DTCA/I, consumer secondary audience

  Electronic Media

  FYI post-approval change/preclearance exemption/what requires review/PAAB scope

  Miscellaneous

  Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists

  Giveaways, Incentives & GIfts, contests, coupons (maybe activities)

  International Conferences

  Linkage Issues

  Patient Info

  Press Releases, Financial Reports, Unsolicited Requests

  Sampling

  Submission Requirements/process & Timelines/eFiles

  Terms of Market Authorization

  Visuals/Layout
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  Hello @llotter
  No, the video is not considered exempt. If the review of the deck did not include the voiceover and/or there are any other additional features (e.g. animations, zoom, pop-ups, footnote presentation etc.), these could all impact the review. This video would require it’s own review.