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  6. Office of Drug Evaluation II (ODE II)
  1. Center for Drug Evaluation and Research | CDER

Office of Drug Evaluation II (ODE II)

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.

Our Mission - The Office of Drug Evaluation II is responsible for protecting the public health by assuring safe and effective drugs and biologics are available to the U.S. population for addiction, allergy, analgesia, anesthesia, diabetes, endocrine, metabolism, pulmonary, and rheumatological conditions.

Immediate Office:

Director: Mary T. Thanh Hai, M.D. (acting)
Deputy Director:  Mary T. Thanh Hai, M.D.
Associate Director for Regulatory Affairs: Sara Stradley
Associate Director for Regulatory Science: Silvana Borges M.D.
Lead Management Officer: Nicole Cooper (acting)
Regulatory Information Specialist: Velma Cunningham
Regulatory Information Specialist: Misbah Baig

Divisions

Mailing Address:

Food and Drug Administration
Center for Drug Evaluation and Research
Office of Drug Evaluation II
5901-B Ammendale Road
Beltsville, MD 20705-1266
Phone: (301) 796-2310
Fax: (301) 595-2124

 
 
 

 

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