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 |