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U.S. Investigational New Drug Application → Types of INDs

There are three types of INDs:

  1. Investigator IND is submitted by a physician who both initiates and conducts the investigation. This physician has immediate supervision over the administration of the investigational drug. This type of IND may be used to study an unapproved drug or an approved product for a new indication.
  2. 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 in accordance with FDA regulations. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
  3. 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.

Categories of INDs

  • Research IND–this category is designated for individual sponsor-investigators
  • Commercial IND–this category is used if the sponsor is either a corporate entity or an NIH institute, or if it is clear that the drug will eventually be commercialized