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  1. Center for Drug Evaluation and Research | CDER

CDER Contact Information

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)

  • Requesting Speakers from CDER

  • 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
      Central Document Room (CDR)
      5901B Ammendale Road
      Beltsville, MD 20705-1266

 

  • 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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