An Investigational New Drug (IND) is a drug or biological product that has not been approved for general use by the Food and Drug Administration (FDA) . It is used in a clinical trial to investigate its safety and efficacy. An IND application is a request for authorization from the FDA to administer an investigational drug or biological product to humans. There are three types of INDs: Investigator IND, Research IND, and Treatment IND. An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population. Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place. Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND.

The IND application must contain information in three broad areas: animal pharmacology and toxicology studies, manufacturing information, and clinical protocols and investigator information. The FDA reviews the IND to ensure that the proposed study is safe and that the risks to study participants are minimized. An IND must be authorized prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.

In summary, an IND is ...