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  1. Center for Drug Evaluation and Research | CDER

Division of Medical Imaging Products (DMIP)

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 Products (DMIP) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologic Licensing Applications (BLAs) for small molecule agents and biologics used in medical imaging.

  • 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.
     

Mailing Address:

Food and Drug Administration

Center for Drug Evaluation and Research

Division of Medical Imaging Products

5901-B Ammendale Road

Beltsville, MD 20705-1266

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