Study included in product monograph, but not in its entirety



  • There is a study that was included in an Rx product monograph. However, only certain components of the study were included in the product monograph. Since the study was accepted to be included in the product monograph, would we be allowed to use the components within the study that were not included in the product monograph?



  • Hey @NatBourre
    As per Q&A 529, “Study findings which are not presented in the TMA (whether because that study is not in the TMA or because the portion of the study in question is not in the TMA) can be considered in drug advertising provided the study meets all provisions in the PAAB code and guidances”. Some elements to consider are that the outcome is consistent with the indication and outcomes presented within the TMA and that the reference is a published and peer-reviewed study which is blinded, randomized, controlled and designed a priori to measure the outcomes. Components of the study which would be considered outside of the limitations of the indication would not be considered.


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