Assessing the Safety and Cost-Effectiveness of Early Nanodrugs

(2009) 16 Journal of Law and Medicine 822

24 Pages Posted: 28 Apr 2013

See all articles by Timothy Vines

Timothy Vines

Civil Liberties Australia; RegNet

Thomas Alured Faunce

Australian National University

Multiple version iconThere are 2 versions of this paper

Date Written: 2009

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.

Keywords: nanotechnology, nanomedicine, PBS, TGA, safety, Australia, Abraxane

Suggested Citation

Vines, Timothy and Faunce, Thomas Alured, Assessing the Safety and Cost-Effectiveness of Early Nanodrugs (2009). (2009) 16 Journal of Law and Medicine 822. Available at SSRN: https://ssrn.com/abstract=2257096

Timothy Vines (Contact Author)

Civil Liberties Australia ( email )

PO Box 7438
FISHER ACT 2611, 04043
Australia

HOME PAGE: http://www.cla.asn.au

RegNet ( email )

Australian National University
Building #8
Canberra, Australian Capital Territory 0200
Australia

Thomas Alured Faunce

Australian National University ( email )

Canberra, Australian Capital Territory 0200
Australia
61 2 61253563 (Phone)

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