FDA BEST Initiative


The Biologics Effectiveness and Safety (BEST) Initiative is part of the Center for Biologics Evaluation and Research (CBER) surveillance program that aims to fulfill the requirements for the FDA Amendments Act of 2007. BEST is part of the Sentinel Initiative housed within the Office of Biostatistics and Epidemiology (OBE) and contributes to CBER’s mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, human tissues and cellular products, gene therapies, allergenics, xenotransplantation products and devices related to biologics.

CBER commenced the BEST Initiative in October 2017 as an active surveillance program for biologics. The surveillance of biologics is slightly different from that of drugs so the BEST Initiative was built with those requirements integrated into its building blocks. It leverages real world data (RWD) from multiple electronic healthcare sources and provides evidence for regulatory decisions. The system consists of large-scale administrative claims, Electronic Health Records (EHRs), and linked claims-EHR data sources with a short data lag. It also has access to on-demand sophisticated analytic capabilities to interrogate the data sources with simple or complex studies. 

PEDSnet is one of the BEST Initiative’s partner organizations. PEDSnet is collaborating with the BEST Initiative on a data characterization project that aims to estimate background rates of COVID-19 vaccine-related adverse events of interest in the general population and counts of vaccine exposures in the general population using existing PCORnet/OMOP data. After the initial exploratory phase, future project aims may include expanding the CDM to improve available vaccine data, conducting chart reviews to look for exposure and outcome validation, and developing new, innovative methods to address automated reporting of adverse events for CBER-regulated products.