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)
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