CBER Labeling Changes Related to Safety Findings that Used Real-World Evidence – FDA and Sponsor Conducted Studies
The FDA and sponsors utilized real-world data and real-world evidence to support regulatory decision-making and safety-related labeling changes for products regulated by the Center for Biologics Evaluation and Research (CBER).
This affects sponsors of CBER-regulated products, including vaccines and biologics, as well as functions responsible for postmarket safety monitoring and labeling.
The formal integration of RWE into the labeling process suggests that postmarket data from non-traditional clinical trial sources is increasingly influential in safety signal detection and product lifecycle management. Regulatory teams may need to prepare for more frequent label updates driven by real-world findings rather than relying solely on prospective clinical trials.
Regulatory and pharmacovigilance teams should evaluate their internal RWD/RWE pipelines to ensure data quality is sufficient for potential label negotiations. Monitoring of postmarket data should be standardized to align with how FDA assesses safety signals that may lead to label modifications.
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