"Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed Phase I of a clinical trial, but has not been approved for general use by the United States Food and Drug Administration.
"Phase I of a clinical trial" means the stage of a clinical trial where an investigational drug, biological product, or device has been tested in a small group for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
"Terminal illness" means a disease that, without life-sustaining measures, can reasonably be expected to result in death in 24 months or less.
(Source: P.A. 99-270, eff. 1-1-16 .)
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