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  1. Center for Drug Evaluation and Research | CDER

Division of Oncology 3 (DO3)

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 3 (DO3) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for Gastrointestinal, Superficial cutaneous cancers, melanoma and sarcoma.

DO3 Management Team

Division Director (Acting), Steven Lemery, MD
Deputy Director (Acting): Lola Fashoyin-Aje, MD

Office of Regulatory Operations – Oncologic Diseases (ORO-OD) for DO3

Chief Project Management Staff: Melanie Pierce

Mailing Address:

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Oncology 3 (DO3)
5901-B Ammendale Road
Beltsville, MD 20705-1266

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

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