644 - Hi, I wanted some clarity on the rule below. Essentially, we are allowed to use peer reviewed resources, etc. to support claims, as long as the claim made references a clinical endpoint already captured in our monograph? Specifically, if my label mentioned confirmed disability worsening, but I also have long term data that discusses confirmed disability improvement (diff metric), I would not be allowed to use this? -- 3.2.2 Literature used to support claims contained in the APS must be consistent with the indications, dosage regimens, and efficacy and safety information contained in the Health Canada TMA.
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Two issues jump out here. Firstly, the outcome appears as though it is quite different from the label (level of disability increases in the label vs the level of disability improving in the study). Secondly, even if we change the outcomes to match each other qualitatively, I note that the study outcome is longer term data than the label. It appears from this limited information that it would not be possible to make an argument of consistency with the TMA. Please see questions 529, 626 and 585.
