152 - As per question no.150, can we make a Quality of Life (QoL) claim based on a published peer reviewed study (condition/use on label) when there is no QoL data in the PM?

  • The QOL data is not necessarily required to appear within the product monograph. The PAAB can consider a QOL claim based on a statistically significant improvement (versus an active or inactive comparator)observed in a published and peer-reviewed study which is blinded, randomized, controlled and designed a priori to measure this endpoint. The wording of the QOL claim should precisely reflect the endpoint which was measured. Also note that the indication will be considered in our assessment (e.g. some indications are limited to specific outcomes). Please call if you have any questions.