IND — What It Means in Clinical Trials
Plain English Definition
An IND (Investigational New Drug) application is the formal request a drug company submits to the FDA before testing a new drug in humans. The IND includes laboratory data, manufacturing information, and a plan for clinical trials. The FDA reviews the IND and either allows the trial to proceed or puts it on hold.
Why It Matters
If a trial has an active IND, it means the FDA has reviewed the safety data and allowed human testing to move forward. This is a necessary step before any clinical trial can begin in the United States.
Example
A trial document might note: "This study is conducted under IND 123456." This is the FDA filing number for the investigational drug.
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