Categories

• 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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  Hello @Agency

  We are nearing the end of the initial pilot phase of PAAB's Accelerated Review Options (ARO). At this point, we'd love to receive your feedback regarding this initiative. Your feedback will help us determine whether you see value in PAAB continuing (and potentially expanding) availability of this service offering. Your feedback will also help shape how ARO evolves.

  All responses are anonymous. This survey will only take a few minutes to complete and it may be completed by more than one member in your company. There is therefore no need to coordinate your responses with your colleagues. Feel free to forward the survey to your colleagues such that they can complete it as well. Sharing is caring!!

  The survey can be found HERE

  Thank you for your time!
  PAAB

• 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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  Happy Holidays @Agency and @Manufacturer

  Heading into the holidays, we’ve wrapped up some helpful tips and clarifications for eFile submissions. Take a PEEK! 🎁 (we won't tell)

  We look forward to working together in 2023!
  PAAB

• 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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  @jennifer-carroll Thank you.

• 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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  Posts

  

  Hello @natbourre

  No, but the indication size should be proportional to the claim size Yes, it is acceptable to use the generic name.
• 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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  Hey @constance

  Due to their size, we often receive a portion of the report. The advertiser must include any content that is relevant to the APS presentation in question.