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  1. Center for Drug Evaluation and Research | CDER

Office of Drug Evaluation III (ODE III)


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.

Julie Beitz, M.D.

Director, Office of Drug Evaluation III

Deputy Director, Vacant

DGIEP Director (Acting) - Dragos Roman, M.D.

DDDP Director - Kendall Marcus, M.D.

DBRUP Director - Hylton V. Joffe, M.D., M.M.Sc.

Mission

The Office of Drug Evaluation III is responsible for protecting the public health by assuring safe and effective drugs and biologics are available to the U.S. population for dermatology, dental, gastroenterology, reproductive, and urologic uses and for in-born-errors of metabolism and conditions involving bone metabolism.

Overview

The staff of ODEIII consists of over 130 highly trained physicians, scientists and regulatory project managers with expertise in gastroenterology, dermatology, dental, reproductive, urologic, nutrition, metabolism, pediatrics, internal medicine, pharmacology/toxicology, and regulatory affairs. These professionals work with specialists in other CDER scientific disciplines such as statistics, clinical pharmacology, epidemiology, chemistry, and drug safety to collaboratively review data on new treatments. 

ODEIII is committed to facilitating rapid development, review, and action on promising new therapies. Scientists within the office are working intensively on incorporating innovations in pharmacogenomics, bioinformatics, and clinical trial design into the drug development process. There are three clinical divisions within ODEIII.  The structure is as follows:

ODEIII Structure and Division Therapeutic Areas 

Division of Gastroenterology and Inborn Errors Products Division of Dermatology and Dental Products Division of Bone Reproductive and Urologic Products
Director (Acting) - Dragos Roman, M.D. Director - Kendall Marcus, M.D. Director: Hylton V. Joffe, M.D., M.M.Sc.
Gastrointestinal conditions and inborn errors of metabolism
Dermatology and dental conditions Reproductive and urologic conditions and conditions involving bone metabolism
 

 

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