Adaptive marketing authorization approaches may, in some instances, replace traditional binary regulatory decisions on drug approval with progressive reduction of uncertainty about the benefit–risk profile of a drug through iterative evidence gathering and evaluation. How should the nature of such evidence be determined?
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Acknowledgements
This work was funded by the Dutch Top Institute Pharma. This paper is based on a workshop organized by The Escher Project (a public–private partnership on the development and regulation of medicines) in Amsterdam, The Netherlands, in December 2012. It was supported by a background paper, which is provided as supplementary information S1.
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Susan Forda is an employee of Eli Lilly and company.
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de Jong, J., Grobbee, D., Flamion, B. et al. Appropriate evidence for adaptive marketing authorization. Nat Rev Drug Discov 12, 647–648 (2013). https://doi.org/10.1038/nrd4114
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DOI: https://doi.org/10.1038/nrd4114
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