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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. Center for Drug Evaluation and Research (CDER)

Division of Oncology 1 (DO1)

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.

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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