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Contact CDER
Information about drug products currently in review at FDA is confidential. If you know the manufacturer/sponsor, please contact them directly. We try to respond to each question within 24 to 48 hours.
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Addresses for sponsors submitting
applications:
Other ways to contact us:
Other sources of information:
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Other Contact Information
- 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
- 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
- Mailing Addresses for Therapeutic Biologic Products
- Mailing Addresses for Return of Adverse Event Reports to CDER
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For voluntary reports from healthcare professionals and consumers
MedWatch - Central Triage Unit
5600 Fishers Lane
Rockville, MD 20852-9787
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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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Date created: December 7, 2004; Updated May 2, 2008 |
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