Investigational New Drug
An Investigational New Drug (IND) is a request submitted to the FDA seeking permission to test an unapproved drug in human clinical trials. The application details manufacturing, prior animal study results, and the proposed study protocol before dosing participants.
What is an Investigational New Drug?
An Investigational New Drug (IND) is a submission to the U.S. Food and Drug Administration requesting permission to begin testing an unapproved drug in humans. It marks the transition from laboratory and animal research to the first studies in people.
The application assembles what is known about the candidate so far, including how it is manufactured, results from prior animal testing, and the proposed plan for human studies. Regulators review this package before any participant receives a dose.
Why is the IND important in drug development?
The Investigational New Drug submission is a critical safety checkpoint, because it lets regulators evaluate whether early human testing can proceed without exposing participants to unreasonable risk. Clinical trials cannot lawfully begin until this step is cleared.
It also forces sponsors to lay out their manufacturing controls and study design in detail, creating a documented basis for everything that follows. The IND therefore shapes the entire trajectory of a drug's clinical program.
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