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  5. Office of Specialty Medicine - Division of Medical Imaging and Radiation Medicine (DMIRM)
  1. Center for Drug Evaluation and Research | CDER

Office of Specialty Medicine - Division of Medical Imaging and Radiation Medicine (DMIRM)

The Office of New Drugs is undergoing a reorganization. This site will 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 QualityUntil this page is updated, please use the current contact information presented on this page or contact druginfo@fda.hhs.gov if you have additional questions.

The Division of Medical Imaging and Radiation Medicine (DMIRM) is responsible for drug products used in the image-based diagnosis and monitoring of diseases. Radiology, nuclear medicine, cardiology, surgery, and various other qualified medical specialties obtain and interpret these images in their daily clinical practice. The imaging products include contrast agents used to improve the ability to see inside the body using light, x-rays, ultrasound, or magnetic resonance. Examples include the use of computed tomography to evaluate the blood circulation and to detect early cancer, stroke, or heart disease. Other imaging drug products contain small amounts of radioactivity and are used to reveal information about the structure and function of the body. Examples of these imaging methods include positron emission tomography (PET) and single photon emission computed tomography (SPECT) for evaluating brain or heart conditions. DMIRM is also responsible for drug products used in the treatment of injury caused by radiation or radioactive materials. These treatments work by increasing the elimination of radioactive contamination from the body or by increasing the recovery of critical cells injured by radiation.

Director: Libero (Lou) Marzella, M.D. (Acting)
Deputy Director: Alex Gorovets, M.D. (Acting)

Regulatory Operations

Chief Project Manager: Kyong Kang

Contact Us

Mailing Address:

Food and Drug Administration

Center for Drug Evaluation and Research

Division of Medical Imaging and Radiation Medicine

5901-B Ammendale Road

Beltsville, MD 20705-1266

Phone: (301) 796-2050
Fax: (301) 796-9848