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Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies
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Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies (2012)Regulatory Review of Novel Therapeutics —…Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma (2008)Balancing early market access…Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019 (2022)Cancer Therapy Approval Timin…Introduction and geographic availability of new antibiotics approved between 1999 and 2014 (2018)Introduction and geographic a…New FDA Breakthrough-Drug Category — Implications for Patients (2014)New FDA Breakthrough-Drug Cat…Can the pharmaceutical industry reduce attrition rates? (2004)Priority medicines for Europe and the world (2004)From efficacy to equity: Literature review of decision criteria for resource allocation and healthcare decisionmaking (2012)Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012 (2014)Cardiovascular Drug Development (2015)The Active Society: A Theory of Societal and Political Processes. (1968)Lessons from 60 years of pharmaceutical innovation (2009)Reputation and Power (2014)Approvals of drugs with uncertain benefit–risk profiles in Europe (2015)FDA's Expedited Approval Mechanisms for New Drug Products (2015)Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe (2020)An analysis of FDA-approved drugs for infectious disease: antibacterial agents (2014)Repairing The Broken Market For Antibiotic Innovation (2015)Antibiotic reimbursement in a model delinked from sales: a benchmark-based worldwide approach (2016)Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval (2019)Medical Care Costs Associated with Cancer Survivorship in the United States (2020)A Decade of FDA-Approved Drugs (2010–2019): Trends and Future Directions (2021)
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References

  • 2008Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma229 cited

Cited by

  • 2014New FDA Breakthrough-Drug Category — Implications for Patients119 cited
  • 2022Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-201983 cited
  • 2018Introduction and geographic availability of new antibiotics approved between 1999 and 201469 cited

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