4.6 Article

Adaptive Licensing and Facilitated Regulatory Pathways: A Survey of Stakeholder Perceptions

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CLINICAL PHARMACOLOGY & THERAPEUTICS
卷 98, 期 5, 页码 477-479

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WILEY-BLACKWELL
DOI: 10.1002/cpt.140

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  1. Centre for Innovation in Regulatory Science, London, UK
  2. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands

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Timely access to safe and effective new medicines of societal value is a goal of medicine developers, regulators, and payers. However, medicine development remains a costly and time-consuming activity, with median development times in 2013 of 9.9 years for new molecular entities.(1)

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