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Expanded Access Policy
Under the recently enacted 21st Century Cures Act in the US, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted for expanded access under section 561(b) of the US Federal Food, Drug, and Cosmetic Act.
Read our full policy.