Categories

• About

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

  1
  Topics
  2
  Posts

  

  @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

  7
  Topics
  19
  Posts

  

  Good Afternoon @Manufacturer and @Agency

  With the increase in digital activities and the transitioning of pieces from print to digital or from digital tools to attached digital downloads, clients increasingly find themselves wanting to add tool names and descriptions at some point in the future therefore triggering the need for submission of an APS update.

  With this in mind, PAAB would like to encourage clients to include this information in their initial submission copy deck template moving forward EVEN if there is no immediate plan to include the tool in a digital platform. Note that PAAB will not be requiring this (although we strongly encourage this as it benefits you). By engaging in this best practice, you enable the PAAB to review the document name (for external use) and description within the review of the original tool. This will help to reduce turnaround times during future submissions where the addition of document names and descriptions are required. This may be of particular importance as these submissions tend to be time sensitive, such as conference booth attachments. In some instances, it will even negate the need for PAAB re-submission (e.g., when simply adding to a list of tools on a third-party platform repository of pharma-generated tools for download in a plain text context, which has been predefined such as eCPS)

  You can view the full “Tips” document here

• Tours

  A place for patient and healthcare professional feedback.

  5
  Topics
  5
  Posts

  A

  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.

  1
  Topics
  1
  Posts

  A

  Lets start with a quick registration video.

• Newsletters/Blogs

  Blog posts from individual members

  9
  Topics
  43
  Posts

  A

  If you have comments or questions about the PAAB Forum Quarterly Review or content you'd like to see in the next quarterly update, let us know 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.

  21
  Topics
  28
  Posts

  

  Happy Friday @georgian21

  PAAB Code section 5.1 states “The compared drugs/products have an authorized indication for use in common, and the comparison is related to that use; or, in addition to the common indication for use, a second authorized indication is claimed as an added benefit of the advertised drug”. As such, this type of comparison would not be acceptable.

• Events & Training

  Have more questions about training? Let us know.

  0
  Topics
  0
  Posts
  No new posts.
• Resources

  Guidance on Code Application

  Guidance on Submission Procedures

  Guidance on DTCA / DTCI Regulations

  Myths vs. Facts

  PAAB Icons

  Activities

  External Resources

  PAAB Logo
  86
  Topics
  116
  Posts

  A

  Enter your comments on this document here:

• 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
  802
  Topics
  918
  Posts

  

  Hello @healthymind

  This question cannot be answered as a general question. We would need to assess the TMA content, claim and data within the published study. We suggest submitting as an opinion for a formal review.

  From a general question perspective, we refer you to the PAAB Guidance on Patient Reported Outcomes which outlines specific considerations for PRO, including specific domains/items comprising the PRO instrument.