Hi there, I hope you are doing well! I'm wondering if an association/organization such as SOGC writes a letter endorsing a tool if that will suffice as an acceptable reference to support statements made in the piece. For background, our product has two indications but we do not have a study that supports both equally and therefore PAAB has said we cannot discuss both in the context of a patient profile. If the SOGC provides a letter stating that the use of this product for one patient (because of the benefit of both indications) is standard clinical practice would that help in approving the APS?

This appears to be a review case specific question. We suggest reaching out to the reviewer to determine what level of evidence/support would be required to support the copy in questions as it depends on the indication wording and how the patient case is being presented. In general, an association/organization letter will not supersede the Health Canada TMA or evidence requirements.


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