Real-World Evidence: US FDA Framework Emphasizes Data Fitness And Study Quality

The US FDA’s approach to real-world evidence (RWE) generally, and specifically for supplemental applications seeking new effectiveness labeling claims, will be guided by three key principles: data fitness, study design fitness, and study conduct.

The agency’s RWE framework describes a conceptual approach to evaluating the potential use of evidence generated outside the traditional clinical trial setting to support regulatory decisions about product effectiveness.