Early Access Support

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All SubjectsEarly Access Support

Stakeholders interactions – Patients Affairs Staff

Published by IRDiRC

Clinical DevelopmentRegulatory AffairsResearch and Drug DevelopmentEarly Access SupportPatient EngagementPatient AdviceFDA Regulatory AdvicePatient Affairs StaffPatient Support

At the FDA, the Patient Affairs Staff (PAS) is devoted to supporting cross-cutting patient engagement activities across the FDA. Its mission is to coordinate and support patient engagement activities across FDA to facilitate awareness and collaboration with patients, their advocates and the FDA

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Single Patient Expanded Access

Published by IRDiRC

Early Access SupportOrphan DrugSingle Patient Expanded AccesssOrphan MedicineResearch and Drug DevelopmentRegulatory Affairs

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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