About FDA

Office of New Drugs - Office of Drug Evaluation I (ODE I)

Office Director: Ellis F. Unger, M.D.
Deputy Director (acting): Robert Temple, M.D. 

The Office of Drug Evaluation I consists of three review divisions: The Division of Cardiovascular and Renal Products, Division of Neurology Products, and the Division of Psychiatry Products. The Immediate office oversees the development, review, and regulation of applications for drug and biologic products reviewed in these divisions.

  • Immediate Office
    • Director: Ellis F. Unger, M.D.
    • Deputy Director (acting): Robert Temple, M.D.
    • Associate Director for Regulatory Affairs: Colleen LoCicero, R.Ph.  

Contact Us

Mailing Address: 10903 New Hampshire Avenue, Silver Spring, MD 20993
Building 22, Suite 4200
Phone: (301) 796-2270
Fax: (301) 796-9840

Page Last Updated: 03/29/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English