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  1. Center for Drug Evaluation and Research | CDER

Division of Oncology Products 2 (DOP2)

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 Products 2 (DOP2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for the following therapeutic areas: gastrointestinal, lung, and head and neck cancers; neuro-oncology, rare cancers, pediatric solid tumors, and melanoma and sarcoma.

Management Team
Director: Patricia Keegan, MD
Deputy Director: Joseph Gootenberg, MD
Associate Deputy Director: Steven Lemery, MD, MHS
Deputy Director for Safety: Jeff Summers, MD
Safety Regulatory Project Manager: Karen Hennessy, RN, MS, CPNP
Associate Director of Labeling (Acting): Stacy Shord, PharmD
Chief Project Management Staff: Melanie Pierce
Chief Project Management Staff: Monica Hughes, MS
Administrative Support Assistant: Charles Lewis

Mailing Address:

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Oncology Products 2 (DOP2)
5901-B Ammendale Road
Beltsville, MD 20705-1266

Phone: (301) 796-2320
Fax: (301) 796-9849

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