FDA's Focus on Real-World Evidence in Regulatory Decision-Making

Aug 14, 2025

Explore how Real-World Evidence (RWE) is impacting FDA decision-making and healthcare's future. This comprehensive overview shows how the FDA is using Real-World Data to amplify clinical trials, accelerate therapies and device approvals, safeguard effectiveness, and inform patient-centred innovations. You will learn about revolutionary initiatives such as the 21st Century Cures Act, AI and digital health initiatives, and international discussions on standardization. No matter if you are in pharma, MedTech, or the broader healthcare ecosystem, this overview of RWE demonstrates why embracing highquality data and real-world experience

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