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Qdossier Qsauri
"I"

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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