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  6. Office of Immunology and Inflammation - Division of Rheumatology and Transplant Medicine (DRTM)
  1. CDER Offices and Divisions

Office of Immunology and Inflammation - Division of Rheumatology and Transplant Medicine (DRTM)

The Division of Rheumatology and Transplant Medicine (DRTM) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics Licensing Applications (BLAs) for prescription drugs and biologics intended for the prevention, treatment, or diagnosis of conditions including:

  • Rheumatological conditions, including (note: drugs for pain due to these conditions are regulated by DAAAP)
    • Rheumatoid arthritis (RA),
    • Juvenile idiopathic arthritis (JIA),
    • Ankylosing spondylitis (AS),
    • Psoriatic arthritis (PsA)
    • Gout
    • Systemic lupus erythematosus (SLE)
    • Systemic Sclerosis
    • Vasculitis, including Giant Cell Arteritis (GCA), Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
    • Myalgic Encephalomyelitis/Chronic fatigue syndrome (ME/CFS)
    • Familial Mediterranean fever (FMF)
    • Oral corticosteroids
  • Solid Organ Transplant
    • Prevention and management of Ischemia Reperfusion Injury after Transplantation.
    • Prevention and treatment of acute T-cell mediated rejection (TCMR) and chronic active TCMR after Transplantation.
    • Prevention and treatment of acute antibody-mediated rejection (ABMR) and chronic active ABMR after Transplantation.
    • Management of immunosuppression for Transplant patients with viral infections: cytomegalovirus (CMV), BK virus (BKV), and Epstein-Barr virus (EBV).
    • Interventions to improve long-term patient and graft survival after Transplantation.

Contact Us

Mailing Address:

Food and Drug Administration
Center for Drug Evaluation and Research
Division of Rheumatology and Transplant Medicine
5901-B Ammendale Road
Beltsville, MD 20705-1266
Phone: (301) 796-2300
Fax: (301) 796-9728

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