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    Canada and the Orphan Drug Framework--Where Are We Now?

    Canada, one of the few developed countries without an orphan drug policy, is finally in the last stages of developing one. In the past, when queried about the lack of a policy, representatives from the country’s food and drug regulatory agency, Health Canada, stated that physicians could apply to have patients receive a non-approved orphan drug through the Special Access Programme or through clinical studies (if conducted in Canada). For manufacturers of orphan drug...