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  1. CDER Offices and Divisions

Expanded Access Single-Patient Emergency (EIND) or Non-Emergency Investigational New Drug Applications (SPIND) for Antiviral Products

The following information is to be used by physicians to request an Expanded Access (EA) Single-Patient Investigational New Drug Application (SPIND) non-emergency or an Emergency IND (EIND) for an antimicrobial product regulated by the Center for Drug Evaluation and Research (CDER), Division of Antivirals (DAV), when a treating physician has determined that the probable risk and benefit to the patient is appropriate. DAV regulates products that are being developed to treat infections caused by viruses (e.g., influenza, hepatitis, respiratory syncytial virus (RSV), human immunodeficiency virus 1 [HIV-1], and adenovirus).

Requests for products not regulated by CDER/DAV should be directed to the appropriate point of contact for the FDA Center/Division in which the product is regulated. [See Office of New Drugs, OND Office and Division Contact Information]. If the appropriate CDER review Division is unknown, please contact the Division of Drug Information (DDI) at 301-796-3400 or 855-543-3784, 301-431-6353 (fax) or druginfo@fda.hhs.gov or DDI.eIND@fda.hhs.gov.

Additionally, for general questions, you may contact the Patient Affairs Staff at 301-796-8460 or patientaffairs@fda.hhs.gov.

I. DURING NORMAL BUSINESS HOURS (8:00 a.m. - 4:30 p.m. Eastern Time, Monday-Friday)

Please visit the following webpage for instructions on requesting an EIND or SPIND: For Physicians: How to Request Single Patient Expanded Access (“Compassionate Use”)

For Step-by-Step instructions see Expanded Access | How to Submit a Request (Forms)

For additional information about Expanded Access for patients, physicians, industry and institutional review boards please visit: Expanded Access

WHERE TO SUBMIT 
Once form(s) have been completed* and Letter of Authorization obtained, submit the request, along with contact information (phone number and email), to the Division via one of the following:

For non-emergency SPINDs* and during Normal Business hours ONLY for EINDs**

(1) Email: DAVPEINDREQUEST@fda.hhs.gov or via facsimile 301-796-9883. Please include telephone number where you can be reached in case additional information is needed.

Alternate options for Non-Emergency SPIND submissions Only

(2) Expanded Access at Reagan-Udall Foundation for the FDA website

(3) CDER NextGen Portal; note forms must be in PDF format

II. AFTER-HOURS [for Emergency INDs]) (After 4:30 p.m. ET weekdays and all day on weekends and Federal Holidays [see contact information in the table in the following link: For Physicians: How to Request Single Patient Expanded Access (“Compassionate Use”)

*Note: Single-patient expanded access INDs will be processed and IND# issued within 48 hours unless submitted on a weekend or holiday; weekend or holiday submissions will be processed on the next business day.

**For Emergency INDs, forms must be submitted within 15-days of authorization.

FOLLOW-UP SUBMISSIONS 
Please see “Follow-up Submissions” section available at the following link regarding Safety Reports, Amendments, Summary of Treatment (closure of IND/withdrawal request), and Annual Report Requirements at: For Physicians: A Guide to Non-emergency Single Patient Expanded Access Submissions

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