Assessing the safety and cost-effectiveness of early nanodrugs

Thomas Faunce, Thomas Faunce, Timothy Vines

    Research output: Contribution to journalArticle

    Abstract

    This article provides a detailed examination of how the safety and cost-effectiveness elements of Australia's drug regulatory system will respond to nanomedicines. The case study investigated involves Abraxane, a newly developed anti-cancer agent. The article concludes by proposing some responses to the challenges which nanomedicines are likely to present to international and domestic agencies. Additionally, it considers whether the recommendation of the Australian Productivity Commission to allow parallel submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) and the Therapeutic Goods Administration (TGA) is appropriate when applied to new nanotherapeutics.
    Original languageEnglish
    Pages (from-to)822-845
    JournalJournal of law and medicine
    Volume16
    Publication statusPublished - 2009

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