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  1. Safety & Availability (Biologics)

CBER Biologics Effectiveness and Safety (BEST) System

The Biologics Effectiveness and Safety (BEST) System was launched in October 2017 to expand and enhance CBER access to new and better data sources, methods, tools, expertise and infrastructure to conduct surveillance and epidemiologic studies. BEST is part of the Sentinel initiative and it promotes CBER's Office of Biostatistics and Pharmacovigilance’s (OBPV) mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, tissues and advanced therapeutics.

The vision for BEST is for it to be the pre-eminent resource for evaluating biologic product safety and effectiveness that leverages high-quality data, analytics and innovation to enhance surveillance, real-world evidence generation, and clinical practice that benefits patients.

BEST builds and expands upon activities undertaken as part of previous FDA collaborative studies for biologic product safety and effectiveness. BEST’s objectives are to:

  1. build data, analytics, infrastructure for an active, large-scale, efficient surveillance system for biologic products
  2. develop innovative methods to utilize electronic health records (EHR) effectively and establish automated adverse events reporting, utilizing natural language processing and artificial intelligence

BEST fulfills the requirements of the FDA Amendments Act of 2007 for an active postmarket risk and analysis system covering at least 100 million persons. It supports FDA’s broader mandate outlined in the 21st Century Cures Act. BEST also supports the reauthorization of the Prescription Drug User Fee Act (PDUFA VI) by advancing postmarketing drug safety evaluation through expansion of the Sentinel System and Integration into FDA regulatory activities.

Learn More about FDA’s Postmarket Surveillance Programs:

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FDA's Postmarket Surveillance Programs

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