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  1. Center for Drug Evaluation and Research | CDER

Office of Drug Evaluation I (ODE I)

The Office of New Drugs is undergoing a reorganization. This site may be updated in the near future. Please check back often. For more information, please visit Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality.

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.

Immediate Office

  • Director: Ellis F. Unger, M.D.
  • Deputy Director: TBD

Contact Us

Mailing Address: 

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