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Nat Rev Drug Discov. 2018 Jun;17(6):379-380. doi: 10.1038/nrd.2017.245. Epub 2018 Jan 5.

Accelerated approval of medicines: fit for purpose?

Author information

1
Department of Pharmacology and Therapeutics, University of Liverpool, Ashton Street, Liverpool L69 3BX, UK.
2
Centre for Innovation in Regulatory Science, Friars House, 160 Blackfriars Road, London SE1 8EZ, UK.

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.

PMID:
29302066
DOI:
10.1038/nrd.2017.245
[Indexed for MEDLINE]

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