Accelerated approval of medicines: fit for purpose?

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

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.

MeSH terms

  • Drug Approval / methods
  • Drug Industry / methods
  • Humans
  • Pharmaceutical Preparations / administration & dosage*
  • Risk Assessment

Substances

  • Pharmaceutical Preparations