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• About

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

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  For web security reasons, please register with your professional email.

  You are not required to disclose your email on your profile (this can be managed in settings). While we do encourage using your real name for your account, to promote building a community, it is not required, and you are free to use a user name of your choosing (within the limitations of the Community Forum Guidelines).

  Thank you

• Announcements

  Announcements regarding our community

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  @Manufacturer @Agency

  There's still time to sign up and join over 150 people registered for the interactive Q&A session on the Accelerated Review Options (ARO) pathway and the new submission guidance documents.

  Registration link can be found in the post above. Hope to see you there.

• 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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  If you have not yet seen them, check out our 4 part video series on Upcoming Submission Process and Features

  The videos act as bite sized summaries of the changes coming to the PAAB submission process with the introduction of the Accelerated Review Options (ARO).

  Video 1: What is ARO?
  Video 2: What's new?
  Video 3: Submission Fees
  Video 4: Other Resources

  Let us know what you think below.

• 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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  Topics
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  Posts

  

  Good afternoon @gmc

  The form is not exempt as service oriented messages to patients/HCPs are still subject to review. See FB on PSP enrolment forms for related information.

• 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

  Myths vs. Facts

  PAAB Icons

  Activities

  External Resources

  PAAB Logo

  Accelerated Review Options (AROs)
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  Hey @laraholmes

  It’s unclear what “in this respect” is referring to. “Open text fields” are “blank” by definition as the rep determines the copy. The restrictions for open-text fields are that the manufacturer has confirmed the reps are trained to limit open-text to transactional element with no therapeutic, product or service/tool being mentioned (see full advisory above). It may be beneficial to set up a clarification call so that we can better understand your question. Please reach out to admin to set up a call with me.

• 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)
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  K

  Our client has asked for confirmation as to whether a statement of “Another indication for Product X is now on formulary in province X" (not linked in any way to additional product messages and/or any mention of therapeutic area) meets the conditions of exemption for formulary announcement messages.