Experimental drug
An experimental drug is a medicinal product that has not yet received approval from governmental regulatory authorities for routine use in human or veterinary medicine. A medicinal product may be approved for use in one disease or condition but still be considered experimental for other diseases or conditions.
United States
In the United States, the body responsible for approval is the Food and Drug Administration, which must grant the substance Investigational New Drug status before it can be tested in human clinical trials. IND status requires the drug's sponsor to submit an IND application that includes data from laboratory and animal testing for safety and efficacy. A drug that is made from a living organism or its products undergoes the same approval process but is called a biologics license application. Biological drugs include antibodies, interleukins, and vaccines.In 2018 federal "Right to Try" laws were enacted in the United States, which allows individuals who fit into the criteria to try experimental drugs that are not yet deemed safe.