FDA | Biologics Effectiveness and Safety (BEST)

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 Pharmacovigilance (OBPV) 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.