Compliance and Surveillance
CBER carries out a wide range of compliance and surveillance activities during the "life cycle" of biological products, including:
- Conducting pre-license and pre-approval inspections of manufacturing facilities and products under clinical study.
- Monitoring the safety, purity and potency of biological products through review of:
- Biological Product Deviation Reports (BPDRs) and HCT/P Deviation Reports.
- Investigations into transfusion and donation related fatalities and other adverse events.
- Product recalls.
- Monitoring reports of biological product shortages.
- Initiating regulatory action to address non-compliance with FDA laws and regulations.
- Monitoring of research conducted on biological products and assessing the protection of the rights, safety, and welfare of human research subjects and the quality and integrity of research data
- Monitoring import and export activities
- Reviewing product advertising and promotional labeling
Adverse Events and Product Deviations
- Adverse Event and Biological Product Deviation Reporting (BPDR)
- BPDR Summary Reports
- Blood Donation/Transfusion Fatality Summary Report
- Safety Information
- FDA Recall Information
- CBER-specific Recall Information
- Product Shortages
- Counterfeit Initiative
Imports and Exports