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The recent passage of the 21st Century Cures Act, which took effect in January, highlights the FDA's shift toward incorporating real-world evidence into its decision-making processes. This move signifies a departure from traditional clinical trial models, allowing for a broader scope of data to inform regulatory decisions. The importance of real-world evidence lies in addressing questions concerning the long-term effects and outcomes after clinical trials, particularly for populations that may not have been represented in those studies. This topic is growing in relevance as stakeholders seek to better assess the value and effectiveness of medical interventions.
