CBER Biological Product Approvals that Used Real-World Evidence
The FDA issued an update outlining how the Center for Biologics Evaluation and Research (CBER) utilizes real-world data (RWD) and real-world evidence (RWE) to support biological product approvals and monitoring. This data is used across the product lifecycle, including premarket evaluation and postmarket safety and effectiveness assessments.
Manufacturers of CBER-regulated biological products, clinical operations teams, and regulatory affairs professionals involved in submission strategies using non-traditional clinical trial data.
This update signals a continued institutional acceptance of RWE within CBER for high-stakes regulatory decisions. For industry professionals, this suggests a potential pathway to supplement traditional clinical trial data with RWD to support both initial approvals and label expansions. However, the source provides limited detail on specific evidentiary standards, requiring teams to remain cautious about data quality and trial design integration.
Regulatory and clinical teams should evaluate existing datasets for RWD/RWE utility. Ensure that data collection protocols for postmarket monitoring are robust enough to potentially support effectiveness claims or future supplemental submissions.
The Food and Drug Administration (FDA) uses real-world data (RWD) and real-world evidence (RWE) to support regulatory decision-making across the lifecycle of medical products, including premarket evaluation and postmarket monitoring of safety and effectiveness.
Open in openFDA / FDA.gov