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  1. Center for Drug Evaluation and Research | CDER

Division of Oncology 1 (DO1)

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.

The Division of Oncology 1 (DO1) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for breast, gynecologic, and genitourinary cancers, as well as supportive care (non-hematologic) products.

DO1 Management Team

Director: Julia A. Beaver, MD
Deputy Director: Amna Ibrahim, MD
Supervisory Associate Director: Laleh Amiri-Kordestani, MD

Office of Regulatory Operations – Oncologic Diseases (ORO-OD) for DO1

Chief Project Management Staff: Christy Cottrell

Mailing Address:

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Oncology 1 (DO1)
5901-B Ammendale Road
Beltsville, MD 20705-1266

Phone: (301) 796-2330
Fax: (301) 796-9845

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