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U.S. Department of Health and Human Services

About FDA

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


Office Director (acting): 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 (acting): 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