Skip to content
  • Categories
  • Recent
  • Tags
  • Popular
  • Users
  • Groups
Skins
  • Light
  • Cerulean
  • Cosmo
  • Flatly
  • Journal
  • Litera
  • Lumen
  • Lux
  • Materia
  • Minty
  • Morph
  • Pulse
  • Sandstone
  • Simplex
  • Sketchy
  • Spacelab
  • United
  • Yeti
  • Zephyr
  • Dark
  • Cyborg
  • Darkly
  • Quartz
  • Slate
  • Solar
  • Superhero
  • Vapor

  • Default (No Skin)
  • No Skin
Collapse
Brand Logo

Forum

  1. Home
  2. PAAB Q&A
  3. Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
  4. When the "clinical significance has not been established" footnote is required
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

When the "clinical significance has not been established" footnote is required

Scheduled Pinned Locked Moved Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
2 Posts 2 Posters 498 Views 3 Watching
  • Oldest to Newest
  • Newest to Oldest
  • Most Votes
Reply
  • Reply as topic
Log in to reply
This topic has been deleted. Only users with topic management privileges can see it.
  • K Offline
    K Offline
    kshulist
    wrote on last edited by
    #1

    Hi there,

    I'm a bit unclear as to when the "Clinical significance has not been established" footnote is required. I understand in general that it would be required when non-clinical features are implied to have clinical significance, however, I guess I am unclear on what PAAB considers "non-clinical features". I know it includes MoA and (I think) ingredient-related claims (e.g., "Drug Z contains no added chemicalY"), but beyond that, I am unsure.

    For example, would a claim like "More than X patients prescribed worldwide" require the "Clinical significance has not been established" footnote? Would that be considered a "non-clinical feature"?

    Any help would be greatly appreciated! Thank you very much!

    1 Reply Last reply
    0
    • Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Hey @kshulist

      The disclaimer is generally requested when any non-clinical features/characteristics extend to/may suggest a clinical benefit. This would include experience claims such as the example provided (# of patients worldwide). The disclaimer is presented to be clear that the number of patients worldwide should not be extrapolated to significance of the efficacy or safety profile of the medication. As a courtesy, the copy “prescribed worldwide” would have to be supported with validated global data which tracked prescriptions to validated new patients.

      1 Reply Last reply
      0
      Reply
      • Reply as topic
      Log in to reply
      • Oldest to Newest
      • Newest to Oldest
      • Most Votes


      • Login

      • Don't have an account? Register

      • Login or register to search.
      • First post
        Last post
      0
      • Categories
      • Recent
      • Tags
      • Popular
      • Users
      • Groups