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  1. Center for Drug Evaluation and Research (CDER)

Division of Hematologic Malignancies 1 (DHM1)

The Division of Hematologic Malignancies 1 (DHM1) manages Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologic Licensing Applications (BLAs) for:

  • Acute leukemias and myelodysplastic syndromes
  • Chronic myeloid leukemia and other myeloid neoplasms
  • Supportive care drugs for stem cell transplantation, including for acute and chronic graft-vs-host diseases (GVHD)
  • Supportive care drugs for immune effector cell therapies, including cytokine release syndrome (CRS)

Mailing Address

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Hematologic Malignancies 1 (DHM1)
5901-B Ammendale Road
Beltsville, MD 20705-1266

Phone: (301) 796-4969
Fax: (301) 837-6142

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