Definition · Plain-language
Investigational New Drug (IND)
An Investigational New Drug (IND) application is the request that allows a sponsor to ship an unapproved drug across state lines and begin human clinical trials under FDA oversight.
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Why an IND is needed
Federal law generally bars the interstate shipment of a drug that has not been approved by the FDA. Because a clinical trial usually requires distributing an investigational drug to study sites in different states, sponsors need a lawful exemption before testing in humans can begin. The IND application provides that exemption. Once the IND is in effect — typically after a 30-day review period during which the FDA can place a clinical hold — the sponsor may proceed to administer the investigational drug to trial participants under the agreed protocols.
The four types of IND
The FDA describes IND applications by purpose. A commercial IND is filed by a company seeking eventually to market the drug. An investigator IND, also called a research IND, is submitted by a clinician who both initiates and conducts a study. An emergency-use IND allows the FDA to authorise use of an experimental drug in an emergency that does not allow time for a standard submission. A treatment IND permits use of a promising investigational drug for serious conditions while the formal studies and review continue.
What the application must contain
An IND must give the FDA enough information to judge whether participants would be exposed to unreasonable risk. Core components include animal pharmacology and toxicology studies supporting the safety of initial human testing; chemistry, manufacturing and controls information describing the drug’s composition and stability; and the clinical protocols and investigator information describing how the studies will be run. The application is governed by 21 CFR Part 312, and institutional review board oversight and informed consent protect participants throughout.
Key facts
At a glance
- Definition: Application to begin human clinical trials of an unapproved drug.
- Stands for: Investigational New Drug (application).
- Function: Exempts the drug from the interstate-shipment ban for study use.
- Types: Commercial, investigator/research, emergency-use, treatment.
- Review: Generally effective 30 days after submission unless FDA holds it.
- Regulation: 21 CFR Part 312.
Common misconceptions
What people often get wrong
Often heard: An IND is FDA approval to market the drug.
Actually: An IND only permits clinical testing of an unapproved drug; it is not marketing approval. Marketing requires a later New Drug Application or Biologics License Application supported by the trial results.
Often heard: Only pharmaceutical companies can hold an IND.
Actually: Individual physician-investigators can hold an investigator (research) IND to conduct their own studies. The FDA recognises commercial, investigator, emergency-use and treatment IND categories.
Often heard: The FDA must affirmatively approve an IND before trials begin.
Actually: An IND generally becomes effective automatically 30 days after submission unless the FDA notifies the sponsor of a clinical hold. It is an exemption that takes effect, rather than an explicit approval.
