Note: The following information is to be used by physicians who would like to request an Emergency IND for an antiviral product regulated by the Center for Drug Evaluation and Research (CDER)/Division of Antiviral Products (DAVP). Emergency IND requests for products not regulated by CDER/DAVP should be directed to the appropriate point of contact for the FDA Center/Division in which the product is reviewed
A physician may decide to request use of an investigational antiviral product through a single-patient Emergency Investigational New Drug (EIND) application if:
- the physician considers the product may be urgently needed for the patient’s serious or life-threatening condition;
- no satisfactory alternative therapy is available; and
- the patient cannot receive the product through any existing clinical trials or expanded access protocols
For general information about single-patient use of investigational products, see:
- Final Rule, Expanded Access to Investigational Drugs for Treatment Use (note regulations on last 3 pages)
- Physician Request for an Individual Patient IND under Expanded Access for Non-Emergency Use or Emergency Use
HOW TO REQUEST AN EIND for an investigational drug product regulated in the FDA/CDER Division of Antiviral Products
If the treating physician has determined that the probable risks and benefits to the patient are appropriate for an EIND AND has contacted the manufacturer and obtained agreement (availability of product and right of reference to supporting information), a request may proceed according to the steps below.
1. Complete the following required forms:
- Form FDA 3926 can be used by physicians when submitting requests for individual patient expanded access to investigational drugs, including in emergencies. This form is designed specifically for single patient IND requests. It can also be used for certain submissions to FDA after the initial application is filed (if you have trouble opening this form you may need to open it in Internet Explorer or right click on the form and save it as a PDF). For more information, including instructions, please visit the guidance Individual Patient Expanded Access Applications: Form FDA 3926.
- Physicians will still be able to use Investigational New Drug Application Form 1571 and 1572 for single patient expanded access submissions; however, Form 3926 is developed specifically for these requests and should be easier to complete. Form FDA 1571 and 1572 are still required for other expanded access submissions (e.g., intermediate access or treatment INDs) and for IND submissions by commercial sponsors or drug manufacturers.
- Form FDA 1571 (PDF - 221KB)
- Form 1572 (PDF - 208KB)
- Form FDA 1571 (Instructions) Note: More specific patient information may be required depending on the drug product being requested. If this is the case, you will be notified and provided the appropriate patient information form.
- The forms can be completed, signed electronically, and emailed (preferred method, see instructions in the link above) or the forms can be signed manually then emailed or faxed
In addition to the required forms listed above, include a Curriculum vitae (CV) of the Sponsor (the attending physician or fellow, not a resident) of the EIND. If the person requesting the EIND is not the sponsor-investigator, please call DAVP in advance to discuss how best to proceed.
2a. To obtain an EIND during regular business hours (8:00 am - 4:30 pm Eastern Time, Monday - Friday):
- Send the completed required forms and CV to DAVP by fax 301-796-9883 or e-mail (DAVPEINDREQUEST@fda.hhs.gov). Please include telephone and fax numbers where you can be reached in case we have additional questions or need additional information to support granting of the EIND. If you send the paperwork by fax, please call the Division (301-796-1500) to inform us the fax has been sent.
- If you are unable to reach DAVP, contact CDER’s Division of Drug Information (DDI) at phone: 301-796-3400 or 855-543-3784; fax: 301-431-6353; or e-mail: email@example.com.
- If DDI and DAVP are not available, contact the CDER Emergency Coordinator (CEC) of the Counter-Terrorism and Emergency Coordination Staff (CTECS) at phone: 301-796-9900 or 301-796-2210; fax*: 301-431-6356; or e-mail at : firstname.lastname@example.org . * Please call or e-mail the CDER Emergency Coordinator before faxing documents.
- Once we receive the required completed forms and CV, and a Medical Officer reviews it, you will be contacted by our Regulatory Project Management Staff. If granted, an EIND number will be assigned and provided to you. Please provide the EIND number to the drug manufacturer for release of the drug.
2b. To obtain an EIND after regular business hours (weekdays after 4:30 pm or before 8:00 am Eastern Time; weekends or holidays):
- Call the FDA Emergency Coordinator at 1-866-300-4374. You will be placed into contact with an FDA staff member who can facilitate or grant your request. Please note that you will not be given an EIND number if your request is granted outside of regular business hours. Provide the drug manufacturer with the name of the person who authorized the EIND for release of the drug.
- Send the completed required forms and CV to DAVP by fax (301-796-9883) or email (DAVPEINDREQUEST@fda.hhs.gov). Please include telephone and fax numbers where you can be reached.
- A member of our Regulatory Project Management Staff will follow up with you the next business day to request any additional information needed to complete your request and to provide you with an EIND number. Please provide the EIND number to the drug manufacturer.
3. If the EIND is granted, mail the original paperwork (paperwork you faxed or emailed to the Division) and two (2) copies to:
Food & Drug Administration
Center for Drug Evaluation and Research
Division of Antiviral Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
4. At the conclusion of product use (whether because of completion/discontinuation of treatment, if the patient dies, or if you have decided not to treat this patient with this investigational product), please submit a request to withdraw the EIND, along with FDA Form 1571, to the address above. Please include information on the results of the treatment, and the disposition of any unused supplies of the drug.
In addition, if treatment is interrupted because the patient experienced an adverse reaction while receiving therapy that leads to discontinuation, we recommend that you follow the patient until the event is resolved, then submit your withdrawal request and include information on the patient and adverse experiences.
Note: Sponsors or institutions contemplating repeated EIND requests for the same product should give early consideration to submission of an IND protocol into which multiple patients can be enrolled, rather than relying on multiple individual-patient EINDs.
Division of Antiviral Products
Director: Debra Birnkrant, M.D.
Deputy Director: Jeffrey Murray, M.D., M.P.H.
Chief, Project Management Staff: Karen Winestock
Building #22, Room 6329
10903 New Hampshire Avenue
Silver Spring, MD 20993