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  7. Emergency IND Timeline
  1. Investigational New Drug (IND) Application

Emergency IND Timeline

General Timeline for Submission of Individual Patient Expanded Access Application for Emergency Use

The following information is intended to provide an overview of timelines applicable to physicians who plan to submit or have submitted individual patient expanded access applications for emergency use. For additional information and a comprehensive explanation of submission requirements, physicians should review regulations at 21 CFR part 312, and the Guidance for Industry: Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers; June 2016 (Updated October 2017).

Individual Patient Expanded Access IND Application for Emergency Use: Initial Submission

TimeActionSupporting Documentation
Day 0-1Contact sponsor/manufacturer to obtain their agreement to provide expanded access to the investigational drugLetter of authorization from sponsor/manufacturer granting a right of reference to the information contained in their  existing IND
  • Letter of Authorization (see online template) to be sent to FDA at the time of application submission by Day 15
Day 1Call FDA to obtain FDA authorization for the expanded access useInformation will be requested by the FDA representative and can be provided via phone, fax, or e-mail
Day 1Obtain informed consent from patient or their legally authorized representative prior to administering treatment 
Post-treatment by Day 5Notify Institutional Review Board (IRB) of the emergency expanded access useSupporting documentation as required by the respective applicable IRB
By Day 15

Submit the expanded access IND application to the appropriate Review Division in the Center for Drug Evaluation and Research (CDER) at FDA

Insert your IND number, provided to you by FDA staff, in the appropriate section of the application form (e.g., section titled, Physician’s IND Number in section 3 of Form FDA 3926)

Form FDA 39261

Letter of Authorization2 from sponsor/manufacturer

 

1Form FDA 1571 and 1572 are also accepted, however, Form FDA 3926 is a streamlined form created specifically for individual patient IND submissions, including those for emergency use.

2In the absence of a Letter of Authorization from the  sponsor/manufacturer, the expanded access IND application’s sponsor is responsible for providing the following in the IND application submission:
  • Description of the facility where the drug is manufactured;
  • Chemistry, manufacturing, and controls information adequate to ensure the proper identification, quality, purity, and strength of the investigational drug;
  • Pharmacology and toxicology information adequate to conclude that the drug is reasonably safe at the dose and duration proposed for the emergency use.

Individual Patient Expanded Access IND Application for Emergency Use: Subsequent Submissions 

Submission/TimeActionSupporting Documentation
Mandatory Safety Reports – Unexpected Fatal or Life-Threatening Adverse Reactions:
As soon as possible but no later than 7 calendar days
Report unexpected fatal or life-threatening suspected adverse reactions3
Mandatory Safety Reports – Other:
As soon as possible but no later than 15 calendar days after determining the suspected adverse reaction  qualifies for reporting
Report serious and unexpected suspected adverse reactions3
Follow-up to a Written Safety Report:
As soon as the information is available but no later than 15 calendar days after the sponsor receives the information
A follow-up report to an IND safety report
IND Application Amendments: Throughout the IND application life cycleFor example, any change in the patient’s treatment plan (generally required to be submitted prior to implementation)
  • Form FDA 39264 with the appropriate box checked in Field 9 Explanation of the changes
Results Summary:
Following completion of the treatment for emergency use
Submit a written summary of the results of the emergency use of the investigational treatment to FDA
  • Form FDA 39264 (Field 9: Summary of Expanded Access Use [treatment completed])
  • Written report that includes the results of treatment, patient response, and all adverse effects.
  • At this time, a request to close the application should be sent to FDA.
IND Application Annual Reports:
Within 60 days of the anniversary of FDA’s original authorization date
(so long as the application remains active)
Submit Annual Report to FDA
  • Form FDA 39264 (Field 9: Annual Report)
  • A brief report of the treatment progress to include: Summary of treatment results, safety information, and any other information, as relevant.

3Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies; December 2012.

4Instructions for filling out Form FDA 3926

 

Questions? Contact the Division of Drug Information (855) 543-3784 or druginfo@fda.hhs.gov