Emergency Investigational New Drug (EIND) Applications for Antimicrobial Products

1. Complete the following forms:

• Emergency Investigational New Drug Application (EIND) Information Request Form (PDF-27KB)
• Form FDA 1571 (PDF-221KB)
• Form FDA 1571 (Instructions)
• Form FDA 1572 (PDF-208KB)

2. Fax the completed paperwork to (301)796-9883, along with a CV of the primary investigator. Please call to inform us the fax has been sent.

3. Once we receive the completed forms and a Medical Officer approves them, you will be contacted with an EIND number. Please include a telephone number where you can be reached along with a fax 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

If you have any questions please call (301)796-1500.

5. To obtain an EIND after regular business hours (8:00 am – 4:30 pm EST) please call (301) 443-1240. You will be placed into contact with a member of the Division of Antiviral Products.

Division of Antiviral Products

Director: Debra Birnkrant, M.D.
Deputy Director: Jeffery 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