Glossary of Terms

Investigational New Drug Application (IND)

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Clinical: Biopharma
Drug Trials

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Once an application is submitted, the FDA has 30 calendar days to review. The FDA will not approve or clear the IND application. If no clinical hold is put placed within that time, then the Investigator may proceed.