Office of Drug Evaluation I (ODE I)
Phase II of OND’s reorganization began on November 4, 2019. The Division of Neurology Products, which split into Division of Neurology I & II, and the Division of Psychiatry Products, which is now the Division of Psychiatry, are now part of the Office of Neuroscience. As a result, the Office of Drug Evaluation I now consists of two review divisions: The Division of Cardiovascular and Renal Products as well as the Division of Hematology Products (DHP), which is in transition until Phase IV. Currently, DHP is reviewing non-malignant hematology products only. The Immediate Office of ODE I oversees the development, review, and regulation of applications for drug and biologic products reviewed in these divisions.
- Director: Ellis F. Unger, M.D.
- Deputy Director: TBD
10903 New Hampshire Avenue, Silver Spring, MD 20993
Building 22, Suite 4200
Phone: (301) 796-2270
Fax: (301) 796-9840