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