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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).

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• Announcements

  Announcements regarding our community

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  In the coming weeks, you may notice some new titles in the signatures on your review letters. With the growth of our team, we have created opportunities for Reviewers to take on new roles and responsibilities within the Review Team at PAAB.

  The most significant change is that we have created a new role within the ‘Reviewer’ umbrella. The role of Senior Reviewer will now be the title to recognize Reviewers who have an expanded scope of responsibility within the team at PAAB.

  We are pleased to announce that the following Reviewers have accepted the role of Senior Reviewer:

  Danielle Anthony Lucia Kim Maxine Armstrong Malika Ladha Vivien Fong Jehan Lalani-Carbone

  We are also pleased to announce that our previous team of Senior Reviewers will now hold the following titles: Jennifer Carroll – Director of Communications Pauline Dong – Director of Policy Yin Man – Director of Preclearance Services

  What impact does this have on your day-to-day experience with PAAB?
  Very little, as the expanded roles relate to internal functions at PAAB. Our review teams for each brand will not be affected by these new roles and you will continue to see your primary Reviewers on your brands, regardless of title. Reviewers, Senior Reviewers, and Directors will all continue to do reviews.

  Escalations will continue to be managed by Yin Man, Director of Preclearance Services.

  Thank you,
  The PAAB Team

• Tours

  A place for patient and healthcare professional feedback.

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• 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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  @Agency and @Manufacturer - Please see update above

• 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

  CEI Survey and Tagging System

  HCP Gating

  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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  Happy Friday @iainb

  A symptom tracker that relates to a disease and not medication AE’s or medication outcomes, which contains no branding elements, could be considered exempt if there was no mention of treatment. If the tool speaks to treatment (even in an unbranded context) it would be subject to review. PAAB can provide an opinion if the piece is exempt. If you’ll want to proceed to approval if the piece is not considered exempt, please indicate this in the submission letter.

• 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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  Hello @nimisha

  In the scenario described above, the HCP is the secondary audience. Why do we say that? We say that because a brochure intended to be shared with a patient should be written in patient friendly language (content is based off part III of the TMA). A HCP should not be detailed to off a patient brochure. They are the secondary audience as they will see the brochure before handing it to the patient, but they’ll be viewing it with the understanding that it is patient information.

  Depending on where the holder is intended to be placed, you may also need to consider the consumer regulations. For example, if the holder is intended to be placed in a context that is visible to anyone who enters the examination room, then any openly visible element on the holder (and any exposed section of the brochure) must not exceed the consumer regulations (see Q&A 240 for additional guidance).