CDER Postmarketing Studies that Used Real-World Evidence
The FDA updated its documentation regarding CDER postmarketing studies that utilize real-world data (RWD) and real-world evidence (RWE) to monitor product safety and effectiveness. This update reflects the agency's ongoing use of RWE to support regulatory decisions throughout the medical product lifecycle.
Manufacturers of biological products and pharmaceuticals, as well as departments responsible for postmarket monitoring, clinical evidence generation, and regulatory submissions.
The reliance on RWE for postmarketing studies suggests that the FDA is increasingly integrating non-traditional clinical data into the formal regulatory lifecycle. For industry, this likely underscores the importance of high-quality data collection in clinical practice settings, as these data may be scrutinized for evaluating long-term safety and effectiveness after initial approval.
Regulatory and clinical teams should evaluate internal data capabilities to ensure RWD collection aligns with FDA expectations for postmarketing safety and effectiveness monitoring. Operations should ensure that data systems used for postmarket evidence generation are robust enough to support formal regulatory decision-making.
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