What is an investigational treatment or procedure?
A treatment or procedure is considered to be investigational if it is being tested in people, but has not yet been approved for routine clinical care by the US Food and Drug Administration (FDA). To receive FDA approval, a series of clinical trials have to have shown that the treatment or procedure is safe and effective for the diagnosis, prevention, or treatment of a defined disease or condition. A treatment or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other uses. An investigational treatment may also be referred to as experimental therapy.
