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. Submission Requirements/process & Timelines/eFiles
  4. Series Submission-submitting 1 file for second review
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.

Series Submission-submitting 1 file for second review

Scheduled Pinned Locked Moved Submission Requirements/process & Timelines/eFiles
2 Posts 2 Posters 84 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.
  • E Offline
    E Offline
    ebailey
    wrote on last edited by
    #1

    This question relates to a series submission, where the parent and child files have already been reviewed by PAAB once and multiple comments have been received.

    In order to be efficient, we would like to continue the review with one file in the parent-child group. Are we able to move 1 of the files through the review process to ensure PAAB alignment or do we need to submit all 4 files at once? Can we submit just one of the child files or does it need to be the parent?

    Jennifer CarrollJ 1 Reply Last reply
    0
    • E ebailey

      This question relates to a series submission, where the parent and child files have already been reviewed by PAAB once and multiple comments have been received.

      In order to be efficient, we would like to continue the review with one file in the parent-child group. Are we able to move 1 of the files through the review process to ensure PAAB alignment or do we need to submit all 4 files at once? Can we submit just one of the child files or does it need to be the parent?

      Jennifer CarrollJ Offline
      Jennifer CarrollJ Offline
      Jennifer Carroll
      wrote on last edited by
      #2

      Good Morning @ebailey

      All files do not need to come back together. You can update the parent file and then apply across all the children files. In general, the parent file should be the one being resubmitted; however we understand that there may be practical reasons to resubmit a child file to get it to approval prior to proceeding with the rest of the children and the parent. When this is the case, please outline this for the reviewer. You may also reach out with an email to admin to confirm that the reviewers agree prior to resubmission.

      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