We are looking to develop a patient resource that focuses on a treatment regimen made up of multiple therapies. Our client's product is indicated for use in this regimen in conjunction with these therapies, however, Part III of the Product Monograph only provides an overview (e.g., side effects, dosing guidance, etc.) of our client's treatment. What is the PAAB's opinion on leveraging Part III from the Product Monographs of the other treatments (NOTE: our client is not the DIN holder for these treatments) to develop a patient brochure or similar resource? The main driver behind this is a significant patient and stakeholder demand for a "one-stop-shop" brochure/resource, especially considering many of the additional treatments are genericized and not actively promoting—ultimately there is a gap/unmet need for patients to be comprehensively informed of all treatments and expectations that are associated with this regimen. An overview of any alternative paths forward for this type of resource would be greatly appreciated.
M
matt.s17
@matt.s17
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