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  5. Office of Drug Evaluation I (ODE I)
  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 will 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. Until this page is updated, please contact druginfo@fda.hhs.gov or newdrugstransitionteam@fda.hhs.gov for updates and additional information.

 

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



 
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