Investigational New Drug application (IND)
INDAn Investigational New Drug application is the FDA submission that allows an unapproved drug to be given to people in clinical trials.
Before a company or researcher can ship an investigational drug across state lines and administer it to human subjects, the FDA must review the proposed studies, the manufacturing information and the animal safety data. Once an IND is in effect, trials can proceed under FDA oversight with defined protocols, monitoring and reporting duties. The process exists to protect trial participants and to generate the data an eventual approval would rest on.
Cannabinoid drugs, including the one purified CBD medicine that has been approved, reached the market by this route. Academic studies of CBD in specific conditions also generally run under an IND, which is one reason such research moves slowly. The existence of an IND means a compound is being studied for something; it is not evidence that the compound works, and it confers no approval on consumer products containing the same molecule.