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  1. About FDA

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),
    • Osteoarthritis (OA),
    • 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) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA)
    • Myalgic Encephalomyelitis/Chronic fatigue syndrome (ME/CSF)
    • Familial Mediterranean fever (FMF)
    • Oral corticosteroids
  • Solid organ transplant rejection medicines

Management

Director: Nikolay Nikolov, MD
Deputy Director: Ozlem Belen, MD
Deputy Director for Safety: TBD
Director of Pharm/Tox for Immunology and Inflammation: Andrew Goodwin, PhD

Regulatory Operations

Chief, Project Management Staff: Sandy Barnes

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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