Contains Nonbinding Recommendations
14
questions that are not resolvable through communications with the sponsor or clinical
investigator. In such situations, either IRB may contact FDA for additional guidance. Affected
sponsors and clinical investigators may also contact FDA in these situations. Please use the
following as an initial point of contact:
o
Center for Biologics Evaluation and Research (CBER) - Bioresearch
Monitoring
Branch, Division of Inspections and Surveillance, Office of Compliance and
Biologics Quality
Phone: (301) 827-6221
Email:
industry.biologics@fda.gov
o
Center for Drug Evaluation and Research (CDER) - Office of
Scientific
Investigations, Office of Compliance
Phone: (301) 796-3150
Email:
cder-osi@fda.hhs.gov
o
Center for Devices and Radiological Health (CDRH) - Division of Bioresearch
Monitoring, Office of Compliance
Phone: (301) 796-5490
Email:
bimo@cdrh.fda.gov
If you have specific questions about how to interpret this guidance, please contact FDA by phone
at (301) 796-8340 or by e-mail at
gcp.questions@fda.hhs.gov
.
