OrphanDrug
OrphanDrug
Pharma Knowledge Base

Access Programs

5 programs
Clear
AllNamed PatientCompassionate UseEarly AccessExpanded AccessSpecial Access
Brazil Expanded Access Program
Framework: RDC 204/2017
Patient with serious or life-threatening condition, no registered alternative available
Expanded Access30d
FDA Expanded Access Program
Framework: 21 CFR 312.310-320
Patient with serious or life-threatening condition, no registered alternative available
Expanded Access30d
FDA Expanded Access Program (EAP)
Framework: 21 CFR 312.320
Patient has serious or life-threatening condition; no comparable/satisfactory alternative therapy; potential patient benefit justifies potential risks; patient enrollment in clinical trial not feasible; expanded access will not interfere with investigational trials
Expanded Access30d
Korea Expanded Access Program
Framework: Pharmaceutical Affairs Act
Patient with serious or life-threatening condition, no registered alternative available
Expanded Access30d
Nigeria Expanded Access Program
Framework: NAFDAC Act
Patient with serious or life-threatening condition, no registered alternative available
Expanded Access30d
Drug Access Programs — Named Patient, Compassionate Use & Expanded Access | OrphanDrug