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Compassionate Use

Regulatory

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.

उदाहरण

  • Remdesivir expanded access during COVID-19 pandemic
  • Experimental CAR-T therapy for refractory leukemia
  • EU compassionate use for gene therapies

क्या आप जानते हैं?

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 …