How Real-World Evidence is Impacting Regulatory Decision Making

As we’ve illustrated in four volumes of this booklet series, the role of real-world evidence (RWE) in drug approvals and expansions by regulatory bodies like the Food and Drug Administration (FDA) continues to expand.  

The FDA is “committed to realizing the full potential of fit-for-purpose real-world data to generate RWE that will advance the development of therapeutic products and strengthen regulatory oversight of medical products across their lifecycle.” 

Manufacturers are not taking this lightly, as each year more regulatory submissions are supported by RWE.  

In this volume, we explore the most recent cases of RWE use for regulatory approvals in 2024, including the areas of: 

• Oncology; 
• Respiratory; 
• Dermatology; 
• COVID-19; 
• Nephrology; 
• And rheumatology.