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FDA Good Clinical Practice Contacts

FDA Good Clinical Practice Contacts

For questions, comments or complaints about Investigational New Drug Research:

Center for Drug Evaluation and Research (CDER)
Office of Compliance
Office of Scientific Investigations (HFD-45)
10903 New Hampshire Avenue
Building 51
Silver Spring, MD 20993
Telephone: 301-796-3150

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

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

For contacting the Good Clinical Practice Program:

Good Clinical Practice Program (HF-34)
Parklawn Building, Room 14B-17
5600 Fishers Lane
Rockville, MD 20857
Telephone: 301-796-8340
Fax: 301-827-1169
Email: CDER-OSI-GCPReferrals@fda.hhs.gov

For questions about Enforcement Information:

Office of Enforcement
Division of Compliance Policy (HFC-230)
Office of Regulatory Affairs
15800 Crabbs Branch Way
Rockville, MD 20855
Telephone: 240-632-6852
Fax: 240-632-6861