Unauthorized Use of Content on this Site: 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 correspondence—are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content, or using it for model training or any related purposes, is strictly prohibited without the express prior written consent of PAAB. This includes, but is not limited to, the use of such materials in automated systems, machine learning models, or artificial intelligence applications.
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.
-
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.
