Pre NOC Communications
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If a Company has a product undergoing approval with Health Canada, and it creates a piece that does not mention or allude to treatments/product in any way and it is restricted to disease information only is it exempt from PAAB review? Thank you.
Great question @turnapage
In theory, the piece you described is exempt from PAAB review. However, there are a few key elements I want to reiterate from the question to ensure proper application.
- The piece cannot mention or allude to treatment/product in any way. This means that we are not speaking about a disease mechanism of action to be targeted. We cannot allude to the potentials of changing or modifying this pathway in any way. This includes not mentioning that the company is invested in research in this particular area as this would allude to a product in development.
- It speaks to disease information only. This means that we are not explicitly or implicitly referring to treatments/product (e.g. speaking to potential targets or stating that not addressing a specific pathway is an unmet need).
In summary, we do encourage submission of pre-NOC editorials as discussion in these pieces can easily result in implicit association to treatments/products.
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Great question @turnapage
In theory, the piece you described is exempt from PAAB review. However, there are a few key elements I want to reiterate from the question to ensure proper application.
- The piece cannot mention or allude to treatment/product in any way. This means that we are not speaking about a disease mechanism of action to be targeted. We cannot allude to the potentials of changing or modifying this pathway in any way. This includes not mentioning that the company is invested in research in this particular area as this would allude to a product in development.
- It speaks to disease information only. This means that we are not explicitly or implicitly referring to treatments/product (e.g. speaking to potential targets or stating that not addressing a specific pathway is an unmet need).
In summary, we do encourage submission of pre-NOC editorials as discussion in these pieces can easily result in implicit association to treatments/products.
@jennifer-carroll Thank you very much for the advice.
