FDA Use of Real-World Evidence in Regulatory Decision-Making
The FDA confirmed its ongoing use of real-world data (RWD) and real-world evidence (RWE) to inform regulatory decisions throughout the entire lifecycle of medical products, including both premarket evaluations and postmarket safety and effectiveness monitoring.
Manufacturers of biologic products, clinical research organizations, and regulatory professionals involved in product applications and post-market safety reporting.
The source reinforces that RWE is an integrated component of the FDA's decision-making process rather than a secondary consideration. This suggests that sponsors may have opportunities to utilize non-traditional clinical data to fulfill regulatory requirements for both new product approvals and ongoing safety surveillance. The emphasis on the entire product lifecycle indicates that RWE strategy should likely be established early in development.
Regulatory and clinical teams should evaluate internal capabilities for capturing and analyzing RWD to support product lifecycles. Companies may consider assessing whether their existing postmarket data collection can be leveraged for future premarket submissions or safety monitoring requirements.
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