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The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications
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The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications (2021)The Role of Real‐World Evidence in FDA‐Ap…Current landscape of innovative drug development and regulatory support in China (2025)Current landscape of innovati…Treatment Effects in Randomized and Nonrandomized Studies of Pharmacological Interventions (2024)Treatment Effects in Randomiz…Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making (2022)Contribution of Real‐World Ev…Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence? (2021)Real‐World Evidence in EU Medicines Regulation: Enabling Use and Establishing Value (2021)Real-World Evidence — Where Are We Now? (2022)A basic introduction to fixed-effect and random-effects models for meta-analysis (2010)ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions (2016)The PRISMA 2020 statement: an updated guideline for reporting systematic reviews (2021)An overview of FDA-approved new molecular entities: 1827–2013 (2014)A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions (2021)Trends in the approval of cancer therapies by the FDA in the twenty-first century (2023)
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  • 2022Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making81 cited
  • 2025Current landscape of innovative drug development and regulatory support in China52 cited
  • 2024Treatment Effects in Randomized and Nonrandomized Studies of Pharmacological Interventions14 cited

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