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Food and Drug Administration and European Medicines Agency guidance for MASH drug development, employing two co-primary histologic endpoints: (1) resolution of steatohepatitis without worsening of fibrosis stage

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Including this regulatory process, the US FDA also considers other factors for approving a new drug or product: the drugs intended use and current treatment field, benefit-risk assessment based on well-designed clinical trials, and evaluating uncertainties or incomplete data

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