investigator INDA
- Guideline or reference source
- FDA www.fda.gov
- Definition
- Is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
- Broader Term
- investigational new drug application
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