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Current landscape of innovative drug development and regulatory support in China
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Current landscape of innovative drug development and regulatory support in China (2025)Current landscape of innovative drug deve…Trends in the approval of cancer therapies by the FDA in the twenty-first century (2023)Trends in the approval of can…Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy (2023)Special FDA designations for …Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries (2022)Regulatory Pathways Supportin…Evolution of drug regulations and regulatory innovation for anticancer drugs in China (2022)Evolution of drug regulations…Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019 (2022)Cancer Therapy Approval Timin…The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications (2021)The Role of Real‐World Eviden…Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study (2021)Regulatory and clinical conse…Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015–2020 (2021)Real-World Evidence in Suppor…A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions (2021)A Decade of FDA-Approved Drug…Use of Real-World Evidence to Support FDA Approval of Oncology Drugs (2020)Use of Real-World Evidence to…Project Orbis: Global Collaborative Review Program (2020)Project Orbis: Global Collabo…Me‐too pharmaceutical products: History, definitions, examples, and relevance to drug shortages and essential medicines lists (2020)Me‐too pharmaceutical product…Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval (2019)Food and Drug Administration …An overview of FDA-approved new molecular entities: 1827–2013 (2014)An overview of FDA-approved n…What matters most in commercial success: first-in-class or best-in-class? (2013)What matters most in commerci…An update on the first decade of the European centralized procedure: how many innovative drugs? (2006)An update on the first decade…Deconstructing the Drug Development Process: The New Face of Innovation (2010)Pharmaceutical Innovation in the 21st Century: New Drug Approvals in the First Decade, 2000–2009 (2010)Open innovation in early drug discovery: roadmaps and roadblocks (2015)Profitability of Large Pharmaceutical Companies Compared With Other Large Public Companies (2020)Which type of dynamic indicators should be preferred to predict patent commercial potential? (2023)Competitiveness in follow-on drug R&D: a race or imitation? 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References

  • 2021A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions323 cited
  • 2023Trends in the approval of cancer therapies by the FDA in the twenty-first century288 cited
  • 2014An overview of FDA-approved new molecular entities: 1827–2013211 cited
  • 2021The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications172 cited
  • 2023Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy133 cited
  • 2020Use of Real-World Evidence to Support FDA Approval of Oncology Drugs121 cited
  • 2021Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study112 cited
  • 2020Me‐too pharmaceutical products: History, definitions, examples, and relevance to drug shortages and essential medicines lists94 cited
  • 2022Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-201983 cited
  • 2021Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015–202071 cited
  • 2020Project Orbis: Global Collaborative Review Program68 cited
  • 2006An update on the first decade of the European centralized procedure: how many innovative drugs?68 cited
  • 2013What matters most in commercial success: first-in-class or best-in-class?

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62 cited
  • 2022Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries60 cited
  • 2019Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval59 cited
  • 2022Evolution of drug regulations and regulatory innovation for anticancer drugs in China56 cited
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