This described a method of providing experimental treatment prior to final approval for use in humans. This procedure is employed to treat very sick people when no other treatment options exist. In the USA the term Expanded Access may also be used, which is available in accordance with the (FDA) regulations. Compassionate use is applied when it is acknowledged a patient may benefit from a treatment or a therapy that has not been trialed as long as it can be given relatively safely and when no other alternative therapy is available. In these situations the drug developer or manufacturer must agree to provide access to the drug.

See also:
Drug usage/utilisation review (DUR)
Clinical Trial
Drug-drug interaction
Experimental Drug
Informed Consent