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.
Can we present a side-by-side comparison of the trial design of our product's pivotal trial vs. the trial design of our competitor?
-
If so, what content would be acceptable to include in such a table? Would it be strictly non-clinical data (e.g., patients characteristics & inclusion criteria)? I assume efficacy data would not be permissible given that it would be for 2 independent trials rather than a head-to-head RCT.
-
If so, what content would be acceptable to include in such a table? Would it be strictly non-clinical data (e.g., patients characteristics & inclusion criteria)? I assume efficacy data would not be permissible given that it would be for 2 independent trials rather than a head-to-head RCT.