FDA's Implementation of Real-World Evidence in Drug Approval Processes

The FDA has launched the use of real-world evidence (RWE) in drug approval processes, marking a significant milestone in modernizing regulatory approaches. RWE, derived from real-world data sources such as electronic health records and registries, offers valuable insights into treatment effectiveness, safety profiles, and patient outcomes.

The guidance outlines criteria for the collection, analysis, and validation of RWE, emphasizing its role in supplementing traditional clinical trial data. By incorporating RWE into drug approval processes, decision-making can be enhanced, drug development can be streamline, and improve patient access to innovative therapies.

To read in depth report from FDA please refer to the report:

Reference: USFDA  https://www.fda.gov/media/171667/download