Addressing vaccine and biologics safety
The FDA’s Center for Biologics Evaluation and Research (CBER) recently reached a 5-year agreement with the life sciences segment of Optum to provide data and expertise to evaluate and research biologics and vaccines.
This collaboration will support the Biologics Effectiveness and Safety (BEST) system as it seeks to:
- Build data, analytics, and infrastructure for an active, large-scale, efficient surveillance system for biologic products.
- Develop innovative methods to utilize electronic health records effectively and establish automated adverse events reporting, utilizing natural language processing and artificial intelligence.