We're developing a branded slide deck for HCPs that will include mention of adverse events as stated in the Product Monograph. It is our intent to provide HCPs with information on how to manage adverse events (e.g. educate patients on dietary measures, consider consulting a dietitian to modify patient diet if required, etc.). Is it correct to assume that the information on how to manage adverse events within this branded APS must be supported by a textbook or recognized third-party website/materials?

Yes, for such statements related to the non-pharmacological management of adverse events, we could consider sources such as medical textbooks and websites of authoritative bodies. Keep in mind that we would still assess consistency with the product monograph and additional information may be required.


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