Director:
George Mills, M.D.,
M.B.A.
Deputy Director:
Rafel Dwaine Rieves
Chief, Project Management Staff: Kaye Kang
The Division of
Medical Imaging and Hematology Products (DMIHP)
regulates Investigational New Drug
Applications (INDs), New Drug Applications (NDAs),
and Biologic Licensing Applications (BLAs) for
small molecule agents and biologics used in
two distinct areas: medical imaging and
hematology.
- The medical
imaging products include contrast agents and
radiolabeled pharmaceuticals used for
diagnostic purposes. The imaging products
also include decorporation agents used to
treat individuals exposed to particulate
radioactive materials and radioactive small
molecules used to treat patients.
- The
hematology products include those products
used predominantly as therapeutic agents in
nonmalignant hematological conditions, such
as the treatment of anemias, venous
thromboembolism, and platelet disorders.
Products regulated by DMIHP
Mailing Address:
Food and Drug
Administration
Center for Drug
Evaluation and Research
Division of
Medical Imaging and Hematology Products
5901-B Ammendale
Road
Beltsville, MD
20705-1266
Phone: (301) 796-2050
Fax: (301) 796-9848
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Office of Oncology Drug
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