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.
2 - We are getting a new indication that was based solely on a very small open-label study with a subjective endpoint. The study was not mentioned at all in the PM, however, it was published.
Claims & Support/References for Claims
1
Posts
1
Posters
343
Views
1
Watching
-
We may consider allowing the use of the published, open-label study if they could prove to us that it was the basis of approval. To do this they would have to forward a copy of the S/NDS and any other pertinent correspondence from Health Canada. We could approach Health Canada on their behalf to resolve any contentious issues regarding the acceptability in advertising of their claims related to this study.
