About FDA

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
      Metro Park North VII
      7620 Standish Place
      Rockville, MD 20855 

  • 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 

 

Contact FDA

Toll Free
(855) 543-3784, or
(301) 796-3400
Human Drug Information

Division of Drug Information (CDER)

Office of Communications

Feedback Form

10001 New Hampshire Avenue

Hillandale Building, 4th Floor

Silver Spring, MD 20993

Page Last Updated: 10/03/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.