U.S. FDA’s Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to American consumers. CDER evaluates safety throughout the drug life cycle and maintains a system of postmarketing surveillance and risk assessment programs.
The Sentinel Program is managed in CDER’s Office of Surveillance and Epidemiology and is an important component of CDER’s postmarketing safety system. Sentinel is used to proactively assess the safety of drugs, under real-world conditions, that more closely reflect patient care in the U.S. This capability enhances drug safety monitoring and enables the Agency to systematically assess safety signals identified during premarket testing, as well as signals that emerge after drugs 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 though use of the Sentinel Distributed Database.
Results are used to evaluate safety signals and complement existing systems, including FDA’s Adverse Event Report System (FAERS). This information is reviewed comprehensively by the Agency, balancing the strengths and limitations of each data source, in order to make the most informed regulatory decisions possible on the safe use of medicines.