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.
56 - Can you use a current FDA approved US Prescribing Information as a reference for PK data?
-
The PAAB Code section 3.1 clearly states that all claims must be consistent with the Health Canada approved Terms of Market Authorization (TMA) (e.g. product monograph). The US FDA approved PI would not meet that requirement. The TMA does contain a section referring to pharmacokinetics data and PAAB would look at that section for support.
