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About FDA
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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)
- 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
10903 New Hampshire Avenue
WO51-2201
Silver Spring, MD 20993-0002
- Division of Drug Information
- 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
7500 Standish Place
Rockville, MD 20855
- New Drug Applications (NDAs)
- 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
Contact Us
- (888) 463-6332
- (301) 796-3400
- druginfo@fda.hhs.gov
Human Drug Information
Division of Drug Information (CDER)
Office of Training and Communication
WO51-2201
10903 New Hampshire Avenue
Silver Spring, MD 20993
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