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About FDA

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Contact DSI

 DSI can be contacted via email, telephone, fax, or in writing for answers to questions, providing comments, or complaints about Investigational New Drug Research.

Email: dsi@fda.hhs.gov
Telephone: (301) 796-3150
FAX: (301) 847-8748
Write: Division of Scientific Investigations (HFD-45)
Office of Compliance
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration
10903 New Hampshire Avenue
Building 51
Silver Spring, MD 20993

 

 For questions, comments, or complaints about Investigational New Biological Product Research

Center for Biologics Evaluation and Research (CBER)
Office of Communication, Training & Manufacturers Assistance
Division of Manufacturers Assistance and Training
Manufacturers Assistance and Technical Training Branch
Telephone: 800-835-4709 or 301-827-1800
Website: http://www.fda.gov/cber/manufacturer.htm

For questions, comments, or complaints about Investigational Device Research:

Center for Devices and Radiological Health (CDRH)
Office of Compliance
Division of Bioresearch Monitoring (HFZ-310)
2094 Gaither Road
Rockville, MD 20850
Telephone: 240-276-0125
Website: www.fda.gov/cdrh/comp/bimo.html

 For contacting the Good Clinical Practice Program
 

Food and Drug Administration
Good Clinical Practice Program (HF-34)
Parklawn Building, Room 14B-17
5600 Fishers Lane
Rockville, MD 20857
Telephone: 301-827-3340
Facsimile: 301-827-1169
Email: gcp.questions@fda.hhs.gov
Website: www.fda.gov/oc/gcp

 For questions about Enforcement Information
 

Division of Compliance Policy (HFC-230)
Office of Enforcement
Office of Regulatory Affairs
15800 Crabbs Branch Way
Rockville, MD 20855
Telephone: 240-632-6852
Facsimile: 240-632-6861
Website: www.fda.gov/ora/compliance_ref/bimo

 

    
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