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.
RWE Presentation
-
We submitted for an opinion regarding overall survival data and this was the response "As the "OS data remained immature" per the Cambridge 2021 paper and analyses were "posthoc/exploratory" in nature, claims based on OS data (Claim #4) are not considered (s3.1.1)." Would it be acceptable with the RWE presentation (attention icon, disclaimers, grey box, etc)?
-
Hello @lora_nolan
This is a review question. Per the Community Guidelines (see top right corner), this does not meet the use conditions for the Forum. Please address review questions through the appropriate channels by submitting a ticket for a call with the Reviewer through eFiles.