Biologics Procedures (SOPPs)

These Standard Operating Procedures and Policies (SOPPs) are used by staff in FDA’s Center for Biologics Research and Review (CBER) in the performance of their duties. They are made available here to the public because CBER is committed to being as transparent as possible in how it operates. These SOPPs are organized by area of activity.

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/default.htm