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)

• 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
    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