Investigational New Drug (IND)

An investigational new drug is a specific label that is conferred to a drug that is in development. The label is given by the FDA, and it is a process the FDA uses to see if a drug should be allowed to start clinical trials in humans. Typically, an investigational new drug has to have a significant body of evidence of crude from multiple research studies. These studies usually take place in laboratories and in animals. If the FDA gives the go-ahead for an investigational new drug to begin human clinical trial, trial sites are established, experimental drugs are produced, and the trial proceeds under close supervision to see how effective it is and whether any side effects or complications begin to develop. After human clinical trials have been completed, the FDA will review the evidence to see if the drug warrants full approval.