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Directions to Sponsors of
Emergency Investigational New Drug (EIND) Applications
Office of Antimicrobial Products, Division of
Antiviral Products
1. Complete the following forms:
- Emergency Investigational New Drug Application (EIND)
Information Request Form
[PDF] [Word]
- Form FDA 1571 [PDF]
[Word]
- Form FDA 1572 [PDF]
[Word]
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
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Date created: November 29, 2005, updated June 5, 2008 |
