When considering clinical treatment with investigational products, treating physicians and investigators should ensure that their clinical situation meets the criteria for expanded access IND applications described in Expanded Access IND Application: Overview.
An expanded access IND application for clinical treatment of a single patient in non-emergency setting should be submitted according to Expanded Access IND Application: Contents and Format recommended for expanded access IND applications.
Treating physicians and investigators who are sponsors of expanded access IND applications are responsible for safety reporting, annual reporting, and other types of reporting for their IND applications. The procedures for IND Application Reporting for expanded access IND applications are similar to those for investigational IND applications and, for single patient treatment situations, should be followed to the extent applicable. The requirements for mandatory IND Application Safety Reporting are the same as for any other IND application. Sponsors of expanded access IND applications also have the same Investigators’ Responsibilities as do sponsors of IND applications intended for clinical investigations.
The review time for an expanded access IND application intended for clinical treatment in non-emergency setting is 30 days following FDA’s receipt of the application. The treatment may not begin until an appropriate notification has been received from FDA.
Upon completion of treatment, the sponsor of a single-patient IND application is expected to send to FDA a summary of treatment results including patient’s response, all adverse events, drug disposition, and other relevant information. When submitting this summary report, the sponsor of the application may request FDA to close the IND application.