The use of experimental treatments and drugs that haven't been approved by the FDA for use in humans. This is typically done for very sick people who have no other treatment options, and this use often requires approval from the FDA on a case-by-case basis.
A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy.
a classification of an experimental drug (IND) that is made available to seriously ill patients before the drug is approved for general use. Few drugs get this classification. Compassionate use drugs are usually free to the patient.
With the sponsor's and FDA's consent, an experimental drug may be administered to a sick patient lacking other treatment options through a compassionate use protocol.
A method of accessing experimental interventions before FDA approval, usually for sick patients without other treatment options. See expanded access.
Regulations that allow people who are extremely ill to obtain investigational treatments before approval.