Investigational New Drug
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Investigational New Drug (IND) refers to a new drug or biologic that will be or is being used in a clinical trial. The term also includes a biologic that is used in vitro for diagnostic purposes. INDs have been tested in a laboratory and received approval from the U.S. Food and Drug Administration (FDA) to be tested in people in a research setting after submission and review of an Investigational New Drug Application. A previously FDA approved therapy may still be considered an IND if it is being studied to treat a different disease or condition.

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NCATS Toolkit for Patient-Focused Therapy Development: Participate In Initial Industry-FDA Meetings

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