Contact CDER

Information about drug products currently in review at FDA is confidential. If you know the manufacturer/sponsor, please contact them directly. We try to respond to each question within 24 to 48 hours.

Other Contact Information

• Phone Numbers:
  • Main FDA for general inquiries: 1-888-INFO-FDA (1-888-463-6332)
  • Drug Information: 301-796-3400 (8:00 a.m. - 4:30 p.m. Eastern Time)
  • To submit a report about an Adverse Drug Reaction: MedWatch: 1-800-FDA-1088
    
    
• General inquiries about drug products
  • Division of Drug Information
    10903 New Hampshire Avenue
    WO51-2201
    Silver Spring, MD 20993-0002
    
    
• Mailing Address for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs)
  
  
  • New Drug Applications (NDAs)
    CDER Central Document Room:
    FDA/Center for Drug Evaluation and Research (CDER)
    Central Document Room (CDR)
    5901-B Ammendale Road
    Beltsville, MD 20705-1266
    
    
  • Abbreviated New Drug Applications (ANDAs)
    Office of Generic Drugs
    7500 Standish Place
    Rockville, MD 20855
    
    
• Mailing Addresses for Therapeutic Biologic Products
  
  
  • Investigational New Drug Applications 
  • Required Postmarketing Adverse Experience Information
  • Advertising and Promotional Labeling
  • Reports of Biologic Product Deviations
  • Biologic License Applications (BLAs), BLA Supplements, Annual Reports on Postmarketing Studies, Postmarketing Study Final Reports, Postmarketing Study Correspondence, and Distribution Reports
    
    
• Mailing Addresses for Return of Adverse Event Reports to CDER
  
  

  • For voluntary reports from healthcare professionals and consumers
    
    MedWatch - Central Triage Unit
    5600 Fishers Lane
    Rockville, MD 20852-9787

  • For mandatory reports from regulated industry and IND reporters
    
    Central Document Room
    Center for Drug Evaluation and Research
    Food and Drug Administration
    5901-B Ammendale Rd.
    Beltsville, MD 20705-1266

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Date created: December 7, 2004; Updated May 2, 2008

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