Regulatory Blog

As the role of real-world data (RWD)  and real-world evidence (RWE)  grows in drug development, regulatory decision-making, and...

The integration of real-world data (RWD) into regulatory decision-making is transforming the landscape of pharmaceutical development and...

The integration of real-world data (RWD) in clinical research is revolutionizing the pharmaceutical landscape. The Medicines and...

The U.S. Food and Drug Administration (FDA) has announced a major initiative by opening a public docket seeking comments on the "...

On July 25, 2024, the U.S. Food and Drug Administration (FDA), through its Center for Drug Evaluation and Research (CDER), Center for...