investigational new drug application
- Definition
- The FDA's IND program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND application for safety to assure that research subjects will not be subjected to unreasonable risk. If the application is approved, the candidate drug usually enters a Phase 1 clinical trial.
- Abbreviation for
- INDA
- Narrower Term
- emergency use INDA
- investigator INDA
- treatment IND
- Related Term
- accelerated development
- application type
- investigational new drug
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