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
Time | Action | Supporting Documentation |
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Day 0-1 | Contact sponsor/manufacturer to obtain their agreement to provide expanded access to the investigational drug | Letter of authorization from sponsor/manufacturer granting a right of reference to the information contained in their existing IND
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Day 1 | Call FDA to obtain FDA authorization for the expanded access use | Information will be requested by the FDA representative and can be provided via phone, fax, or e-mail |
Day 1 | Obtain informed consent from patient or their legally authorized representative prior to administering treatment | |
Post-treatment by Day 5 | Notify Institutional Review Board (IRB) of the emergency expanded access use | Supporting 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) | 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.
- 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/Time | Action | Supporting Documentation |
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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 |
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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 |
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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 |
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IND Application Amendments: Throughout the IND application life cycle | For example, any change in the patient’s treatment plan (generally required to be submitted prior to implementation) |
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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 |
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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 |
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3Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies; December 2012.
Questions? Contact the Division of Drug Information (855) 543-3784 or druginfo@fda.hhs.gov