FDA | Biologics Effectiveness and Safety (BEST)

Background

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. The BEST Initiative collaborates with multiple partner organizations that provide access to healthcare data and scientific expertise.