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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. Center for Drug Evaluation and Research (CDER)

CDER Contact Information

Ask a general question

Other ways to contact CDER

Phone numbers

  • Main FDA for general inquiries: 1-888-INFO-FDA​ (1-888-463-6332​)
  • Drug Information: 301-796-3400​ (8:00 AM - 4:30 PM Eastern Time)
  • To submit a report about an Adverse Drug Reaction: MedWatch: 1-800-FDA-1088​ 

Mailing addresses

General inquiries about drug products

Division of Drug Information
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993

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

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

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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