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. Terms of Market Authorization
  4. 326 - Can we create a comparative timeline of 2 products (1 ours and 1 a competitor) from the same therapeutic category and who have some of the same indications? The timelines would only show indications, which ones each product has and when they were received. Thank you.
PAAB Notice
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.

326 - Can we create a comparative timeline of 2 products (1 ours and 1 a competitor) from the same therapeutic category and who have some of the same indications? The timelines would only show indications, which ones each product has and when they were received. Thank you.

Scheduled Pinned Locked Moved Terms of Market Authorization
1 Posts 1 Posters 244 Views
  • 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

    Comparisons of product properties are permissible as per Code section 5.10.2iii. The comparison should be complete, with no information relevant to the comparison omitted (e.g. the indications must each be complete). The comparison must not appear in the context of messaging implying clinical significance. A disclaimer is required as outlined in the above noted Code section. With regards to the dates, keep in mind that there should be no direct or indirect reference to the approval process ad per c.01.007 of the Food and Drugs regulations.

    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