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U.S. Department of Health and Human Services

Drugs

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Emergency Investigational New Drug (EIND) Applications for Antiviral Products

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
 

See: Physician Request for an Individual Patient IND under Expanded Access for Non-emergency or Emergency Use

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:

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:

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.

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.
  • 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.

OR

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 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 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

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