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.
512 - Can you please clarify why product MOA can only come from the TMA, and not published, peer-reviewed in vitro studies? MOA is frequently characterized post-NOC, particularly for products where ‘the exact mechanism of action is unknown’.
Claims & Support/References for Claims
1
Posts
1
Posters
525
Views
1
Watching
-
The qualitative description of a product’s action in advertising must be consistent with its current Terms of Market Authorization in order to satisfy PAAB code section 3.1. Therefore, if the MOA info in the TMA is outdated (e.g. because the MOA is no longer unknown), the TMA is required to be updated in order to include that info in drug advertising.
