Investigational New Drug Application

Investigational New Drug (IND) Application is a request for authorization from the U.S. Food and Drug Administration (FDA) to administer an investigational drug or biologic to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biologic that is not already the subject of an approved New Drug Application or Biologics/Product License Application (21 CFR 312).

An IND application includes results of previous experiments; how, where, and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in animal studies; and how the compound is manufactured.

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National Institute on Aging (NIA) Glossary of Clinical Research Term
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NCATS Toolkit for Patient-Focused Therapy Development: Participate In Initial Industry-FDA Meetings
U.S. Food and Drug Administration (FDA): Investigational New Drug (IND) Application

Synonyms:
IND Application
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