Investigational New Drug Applications for Clinical Treatment with Investigational Drugs in Emergency Situations
An emergency investigational new drug (IND) application is an IND application for the use of an investigational new drug or biological product for clinical treatment of a patient in an emergency situation.
The party who (1) submits a request to open an emergency IND application and (2) receives FDA’s authorization to use the investigational product is considered the sponsor of the emergency IND application. In the absence of any other sponsor (e.g. pharmaceutical company), the treating physician is the sponsor of the emergency IND application.
Following receipt of FDA’s authorization for emergency treatment with an investigational drug or biological product, the appropriate Review Division in the Office of New Drugs should be contacted for all issues related to the application, including inquiries for procedures on dispute resolution (process to resolve a disagreement with the FDA’s decision).
For decisions regarding opening an emergency IND application consider consulting the Emergency New Drug Application Eligibility Tool.
Information that should be sent to FDA with the initial request for emergency treatment authorization may be found in Physician's Checklist for an IND Application for Emergency Treatment.
The timeline and supportive documentation for the initial and subsequent submissions related to an emergency IND application may be found in Emergency IND Application Timeline.