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. Claims & Support/References for Claims
  4. 507 - The PAAB does not allow the use of post-hoc study analyses to support claims. Are there any exceptions to this? For example if the post-hoc analysis was done for safety reasons at the request of the FDA, would that publication be permitted to support claims?
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.

507 - The PAAB does not allow the use of post-hoc study analyses to support claims. Are there any exceptions to this? For example if the post-hoc analysis was done for safety reasons at the request of the FDA, would that publication be permitted to support claims?

Scheduled Pinned Locked Moved Claims & Support/References for Claims
1 Posts 1 Posters 578 Views 1 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.
  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Post hoc analysis is not accepted as evidentiary support for claims of benefit (PAAB s 3.1.1). The only exception which readily comes to mind is if the data is in the Health Canada approved Terms of Market Authorization.

    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