This FDA program allows early access to drugs and medical devices before marketing approval, under regulatory oversight with collection of Safety data, to individual patients with serious or immediately life-threatening diseases or conditions who lack therapeutic alternatives. This includes emergency and non-emergency expanded access.
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Single Patient Expanded Access
Published by IRDiRC
Research and Drug DevelopmentRegulatory AffairsOrphan DrugEarly Access SupportOrphan MedicineSingle Patient Expanded Accesss