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Definition of Compassionate use

Medically reviewed by Min Clinic Staff | Updated: January 2026

Compassionate use: Term formerly used in the US for a method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure was used with very sick individuals who have no other treatment options. Often, case-by-case approval was obtained from the FDA for "compassionate use" of a drug or therapy. The use of this term is now discouraged by the FDA.