@jennifer-carroll Thanks - to clarify, we can present the AE table with the intervention and control arms from the product monograph 'as is' without any safety claim (just a descriptive table title _ Trial X Adverse Events).
M
MBos
@MBos
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.
Posts
-
Safety Information from Product Monograph -
Safety Information from Product MonographIs there any acceptable presentation of the adverse events table including the data for both the intervention arm and the comparator arm in an APS, recognizing the trial was not powered to detect a difference? For multidrug regimens, these tables are useful to HCPs who need to understand which drug in a regimen is responsible for a particular adverse event, in order to inform dose reductions (specifically for trials where regimen ABC is compared to AB).
-
APS stating removal of conditions associated with NOCWhat information should be provided in an APS that is intended to inform HCPs that Health Canada is satisfied that all the conditions (NOC/c) have been met, and the conditions associated with market authorization of a product have been removed? Is it possible to simply state that "the conditions associated with the NOC have been met" and link to the updated Product Monograph?