Investigational New Drug (IND) and Emergency Investigational New Drug (EIND) Application Information

This table provides links to information for investigators about submitting Investigational New Drug (IND) and Emergency Investigational New Drug (EIND) 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	Expanded Access: IND Applications for Clinical Treatment
Overview	Overview	Overview	Overview
Contents and Format	Protocol Amendments	Exemptions from IND Requirements	Contents and Format
Regulatory and Administrative Components	Information Amendments	Interactions with FDA	Emergency IND Timeline (Treatment of a Single Patient in Emergency Setting)
Non-clinical Components	Safety Reports	Clinical Hold	For Physicians: A Guide to Non-emergency Single Patient Expanded Access Submissions
Clinical Components	Annual Reports	Investigator's Responsibilities	Treatment of a Group of Patients