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  1. Center for Drug Evaluation and Research | CDER

Division of Pulmonary, Allergy, and Rheumatology Products (DPARP)


The Office of New Drugs is undergoing a reorganization. This site may 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 Quality.

Director: Sally Seymour, M.D.
Deputy Director:  Banu Karimi-shau, M.D. (acting)
Deputy Director for Safety:  Sally Seymour, M.D. (acting)
Supervisory Associate Director:  Nikolay Nikolov, M.D. 
Chiefs, Project Management Staff: Sandy Barnes and Ladan Jafari
Associate Director for Labeling:
Vacant
Safety Regulatory Project Manager: Carol Hill
Administrative Officer: Stanley Allen
Project Specialist: India Wilson

The Division of Pulmonary, Allergy, and Rheumatology Products (DPARP) 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:

  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Idiopathic pulmonary fibrosis (IPF)
  • Acute respiratory distress syndrome (ARDS)
  • Seasonal and perennial allergic rhinitis (SAR, PAR)
  • Chronic idiopathic urticaria (CIU)
  • Cough and cold symptoms (prescription drug products only)
  • Cough inducers (for challenge tests)
  • Hereditary angioedema (HAE)
  • Anaphylaxis
  • Familial Mediterranean Fever (FMF)
  • 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)
    • Scleroderma
    • Vasculitis, including Wegener’s granulomatosis and microscopic polyangitis
  • Cystic fibrosis (except infections associated with CF)
  • Chronic fatigue syndrome (CFS)
  • Products for critical care (e.g., epinephrine)
  • Surfactants for infant respiratory distress syndrome (RDS)
  • Muscle relaxants
  • Corticosteroids, except ophthalmological and topical
Mailing Address:
Food and Drug Administration
Center for Drug Evaluation and Research
Division of Pulmonary, Allergy, and Rheumatology Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
Phone: (301) 796-2300
Fax: (301) 796-9728

 

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