Unauthorized Use of Content on this Site: 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 correspondence—are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content, or using it for model training or any related purposes, is strictly prohibited without the express prior written consent of PAAB. This includes, but is not limited to, the use of such materials in automated systems, machine learning models, or artificial intelligence applications.
Series Submission-submitting 1 file for second review
-
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?
-
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.
