The U.S. FDA’s Center for Biologics Evaluation and Research (CBER) regulates biologic products and ensures their safety and efficacy. These products include blood and blood products; vaccines; cellular, tissue, and gene therapies. CBER evaluates safety throughout the product life cycle and has integrated the following programs into its regulatory decision-making processes:
- Postlicensure Rapid Immunization Safety Monitoring (PRISM)—A subcomponent of the Sentinel System focusing on vaccine safety surveillance. PRISM has been deployed for refinement and evaluation of potential safety signals identified during premarket and postmarket reviews.
- Blood Safety Continuous Active Surveillance Network (BloodSCAN)—A subcomponent of the Sentinel System focusing on blood and blood product safety surveillance. BloodSCAN has been utilized for assessing safety of different blood products in the premarket and postmarket settings as well.
One characteristic of the Sentinel System is that it enables CBER to proactively assess biologics safety, under real-world conditions, reflecting patient care in the U.S. This capability enhances safety monitoring and allows CBER to systematically evaluate safety signals identified during premarket trials, as well as signals that emerge after products are released to the market.
Sentinel assessments make use of the automated surveillance tools that support FDA’s Active Risk Identification & Analysis System. This approach improves the efficiency of FDA monitoring and ensures patient privacy through the use of the Sentinel Distributed Database.
Results are used to evaluate safety signals. Sentinel assessments complement existing surveillance systems such as the Vaccine Adverse Event Reporting System (VAERS). CBER comprehensively reviews the results from different surveillance sources and considers the strengths and limitations of each data source to make the most informed regulatory decisions possible.