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U.S. Department of Health and Human Services

Drugs

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Investigator-Initiated Investigational New Drug (IND) Applications

This table provides links to information for investigators about submitting Investigational New Drug (IND) applications to FDA. The resources for application reporting and applications procedures apply to IND applications for both clinical research and clinical treatment. 
 

IND Applications for
Clinical Investigations
 
(Product Development)

IND
Application
   Reporting    

IND 
 Application 
Procedures

 IND Applications for
Clinical Treatment

(Expanded Access)

OverviewOverview OverviewOverview 
Contents and Format Protocol
 Amendments
 
Exemptions from IND Requirements Contents and Format 
Regulatory and
Administrative Components
Information
Amendments
 
Interactions
with FDA
Treatment of a Single Patient in Emergency Setting
Non-clinical
Components
  
Safety
  Reports
  
Clinical HoldTreatment of a Single Patient in Non-emergency Setting
Clinical
Components
Annual
  Reports
  
Investigator's
Responsibilities
Treatment of a Group of Patients