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Investigational New Drug Definition
Investigational New Drug (IND) is a new drug in the final phases of development for which the US Food and Drug Administration (FDA) grants restricted approval for use in clinical testing, emergency treatment, or transportation across state lines. Typically the use of an IND must meet one of three requirements:
- The person to receive the IND enrolls in a clinical research study that is evaluating the drug’s effectiveness, benefits, and risks among the drug’s intended patient population.
- The person to receive the IND has a serious or life-threatening condition the IND is being developed to treat, and there are no ongoing clinical research studies in which the person can enroll.
- The person to receive the IND has a serious or life-threatening condition the IND is being developed to treat, and the FDA is in the process of reviewing the drug’s clinical research data.
The most commonly used INDs are antibiotics used to treat multiple-drug-resistant infections and drugs to treat cancer. On its Web site the FDA maintains lists of current INDs by type of drug and information about how to gain access to unapproved drugs (www.fda.gov).
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