Emergency Investigational New Drug (EIND) Applications for Antiviral Products

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

If the treating physician has determined that the probable risks and benefits to the patient are appropriate for an EIND request and has contacted the manufacturer to obtain agreement (availability of product and right of reference to supporting information), a request may proceed according to the steps below, for an EIND for an investigational antiviral product regulated in the FDA/CDER Division of Antiviral Products (DAVP).

1. Complete the following required forms:

• Form FDA 1571 (PDF - 221KB)
• Form FDA 1571 (Instructions)
• Form FDA 1572 (PDF - 208KB)
• Emergency Investigational New Drug Application (EIND) Patient Information Form (PDF - 20KB)

In addition to the required forms listed above, include a Curriculum vitae (CV) of the treating physician; the sponsor-investigator 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.

2. 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).
• Call the DAVP (301-796-1500) to inform us the EIND request has been faxed or e-mailed.
• 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. Please include a telephone number where the sponsor-investigator can be reached along with a fax number, in case we have additional questions or additional information is needed to support authorization of the EIND. After authorization, an EIND number will be assigned and provided to you.

3. To obtain an EIND after regular business hours (weekdays after 4:30 pm or before 8:00 am; weekends or holidays):

• Call the FDA Emergency Coordinator at 1-866-300-4374 or 301-796-8240 or the CDER Emergency Coordinator at 301-796-9900. You will be placed into contact with an FDA staff member who can facilitate or authorize your request.
• Fax the EIND required forms and CV to DAVP. 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.

4. Mail the original forms 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

5. When you have completed treatment of this patient with this investigational product please submit a final report that includes the results of the treatment and a request to withdraw the IND. In addition, please include information on the disposition of any unused supplies of the drug. If you have decided not to treat this patient with this investigational product, notify us so that the IND may be withdrawn.

6. 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 (DAVP)

Director: Debra Birnkrant, M.D.
Deputy Director: Jeffrey Murray, M.D., M.P.H.
Chief, Project Management Staff: Karen Winestock and Victoria Tyson

White Oak
Building #22, Room 6329
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-1500