Compassionate Use
A regulatory pathway that allows patients with serious or life-threatening conditions to access investigational drugs outside of clinical trials when no comparable alternatives exist. Also known as Expanded Access in the US. Requires physician application, sponsor agreement, and FDA/IRB authorization.
示例
- Remdesivir expanded access during COVID-19 pandemic
- Experimental CAR-T therapy for refractory leukemia
- EU compassionate use for gene therapies
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A regulatory pathway that allows patients with serious or life-threatening conditions to access investigational drugs outside of clinical trials when no comparable alternatives exist. Also known as Expanded Access in …