Abstract
The uptake of a new medicine represents a balance between benefit–risk assessment and value considerations. In the case of products approved via accelerated pathways, the increased uncertainty adds to the challenge. Here, we suggest solutions so that regulators, companies, payers and patients can align around management of the uncertainties and expectations.
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Breckenridge, A., Liberti, L. Accelerated approval of medicines: fit for purpose?. Nat Rev Drug Discov 17, 379–380 (2018). https://doi.org/10.1038/nrd.2017.245
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DOI: https://doi.org/10.1038/nrd.2017.245
