Explore more case studies like these in our series
How RWE is Impacting Regulatory Decision Making
How RWE is Impacting Regulatory Decision Making
Advancing Approvals
with Real-World Results
8 FDA-Recognized Success Stories of
Real-World Evidence (RWE) in Regulatory Approvals
The FDA’s stance on RWE has evolved—and life sciences organizations are responding.
Inside the booklet, you’ll learn:
- How sponsors are using linked real-world data and natural history studies to meet FDA evidentiary standards
- Which approvals – from vaccine label expansions to rare disease breakthroughs – successfully leveraged RWE
- What types of study designs and external controls have proven successful in regulatory submissions
- How RWE supported label expansions, accelerated approvals, and rare-disease designations
- Key milestones from the FDA’s Advancing Real-World Evidence Program and recent guidance shaping the next generation of regulatory science
Discover how RWE is shaping the future of regulatory science—and what it means for your next submission.