@jennifer-carroll Thank you for your help
T
turnapage
@turnapage
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Posts
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pre-NOC and post NOC disease state APS -
pre-NOC and post NOC disease state APS@jennifer-carroll thank you for your very helpful response as always!! Just a clarification on the second sentence: I was under the understanding that post-NOC disease state APS that discussed treatments would be reviewed as an editorial under PAAB and additionally you could not allude to a product by discussing mechanism of action (https://forum.paab.ca/search?term=689&in=titlesposts). Is this still correct about post-NOC disease state APS?
Thanks again very much for your time!
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pre-NOC and post NOC disease state APSHi,
It seems to me the rules to create a PAAB-exempt disease state APS the same as the rules to create a PAAB exempt pre-NOC APS (there is no mention of treatments/healthcare products (by name, class, or category); no drug issues are discussed (e.g. adherence, side effects...); no linkage of any kind to drug therapy; not speaking about a disease mechanism of action to be targeted/alluding to the potentials of changing or modifying this pathway in any way; no speaking to potential targets or stating that not addressing a specific pathway is an unmet need). Is this correct?
Thank you very much in advance for your help.
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Pre NOC Communications@jennifer-carroll Thank you very much for the advice.
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Pre NOC CommunicationsIf 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.