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Business - May 29, 2023

Strengthening regulatory submissions for innovative treatments using RWE

The focus on real world evidence (RWE) and its potential to support regulatory decision-making has gained global traction. Regulatory bodies, such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), have released their expectations for the use of real world data (RWD) and RWE. In July 2022, the International Coalition […]

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