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U.S. Department of Health and Human Services

Drugs

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IND Applications for Clinical Investigations: Overview

 

  • Investigational New Drug (IND) Application is submitted to FDA if a drug (or biological product) not previously authorized for marketing in the US is intended to be used for the purposes of clinical investigation or, in certain cases, for the purposes of clinical treatment when no approved therapies are available. 

  • Clinical investigation is defined as “an experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. Such an experiment is any use of a drug [whether approved or unapproved] except for the use of a marketed drug in the course of medical practice." For more information on this definition, consult FDA’s Guidance for Industry (PDF- 210KB)

  • Sponsor of an IND application is the party who submits the application to FDA. In the absence of any other sponsor (e.g. pharmaceutical company), the investigator conducting the proposed clinical investigation is the sponsor of the IND application.

  • Electronic submissions of IND applications and use of data standards are encouraged. Information related to electronic submissions may be found at FDA Study Data Standards Resources.

  • Review Time for initial submission of an Investigational New Drug application is 30 days from the date FDA receives the IND. An IND applicant may proceed with a clinical investigation once the applicant has been notified by FDA that the investigation may proceed or after 30 days if the IND is not placed on Clinical Hold.

  • Exemptions to IND application requirements may be found in IND Application Exemptions.  

  • Address for sending IND applications may be found at Information for Sponsor-Investigators Submitting INDs