single-patient compassionate use
Quick Summary
Single-patient compassionate use, sometimes called a Treatment IND, is a regulatory pathway that allows patients with life-threatening diseases to access unapproved drugs when no satisfactory alternative treatment exists. This process is subject to requirements similar to a regular Investigational New Drug (IND) application.12
The U.S. Food and Drug Administration (FDA) grants this permission in desperate situations where no other treatment options are available. For example, the IND Compassionate Use Program, which allowed patients to receive government-supplied marijuana for specific conditions, was terminated in 1992, though existing patients continued to receive it. Access to investigational drugs can also be gained through participation in clinical trials.23
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