Support for chemotherapy dosing, when no official indication
For a product ("Product Z") that is indicated for "condition X" in combination with chemotherapy, what references are acceptable for dosing for the chemotherapy regimen? The regimen for chemotherapy is not provided in the Product Z monograph. Chemotherapy is primarily generic and TMA's are not often updated, so no chemo drug is yet indicated for "condition X."
Jennifer Carroll last edited by
Code section 1.4c states “The Code applies to Advertising/Promotion Systems generated by advertisers or their agents, wherein the advertiser’s product or a competitor’s product is cited by either trade name or non-proprietary name. This includes any identifiable branding element.”. As such, the dosing for products which should be used in combination with the sponsors product, are required to be aligned with their respective TMA. If the products label does not align (i.e. not indicated in the specific population of reference), the sponsor should limit the copy to directing the HCP or patient to the respective labelling of the products which can be used in combination.
We could provide a more specific assessment in the context of an official opinion submission, providing consideration to all factors that pertain to your particular case (e.g., precise wording in monograph, planned level of specificity of provided dosing info, particular references intended to be cited, and so on).