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Glossary · Tier 2

Investigational New Drug (IND)

Also known as: IND, IND application, Investigational New Drug Application

Verified from FDA on 06-02-2026
Quick answer

An Investigational New Drug (IND) submission is the formal pathway a sponsor uses to move an experimental drug into human clinical trials in the United States. Because federal law restricts interstate distribution of unapproved drugs, the IND functions as a legal exemption that allows sponsors to ship the investigational product to clinical investigators across state lines. The FDA describes the mechanism as follows.

MedivaScan summary. The authoritative source quote follows below.

FDA definition

Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.

U.S. Food and Drug AdministrationView on source ›Verbatim quote. Last verified 06-02-2026.
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