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  1. Center for Drug Evaluation and Research (CDER)

CDER Contact Information

Other ways to contact us:

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 Address for Therapeutic Biologic License Applications (BLAs)
CDER Central Document Room:
FDA/Center for Drug Evaluation and Research (CDER)
Central Document Room (CDR)
5901-B 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 

Additional Contact Information



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