CDER Contact Information

• Contact CDER Form
• E-mail: druginfo@fda.hhs.gov

Other ways to contact us:

• Reference Guide for CDER's main offices and phone numbers
• CDER Ombudsman (If you have a complaint rather than a question)
• 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
    10001 New Hampshire Avenue
    Hillandale Building, 4th Floor
    Silver Spring, MD 20993
• 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 (HFD-600)
    Center for Drug Evaluation and Research
    Food and Drug Administration
    Metro Park North VII
    7620 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