Assessing the Safety and Cost-Effectiveness of Early Nanodrugs

Journal of Law and Medicine, Vol. 16, pp. 822-845, 2009

ANU College of Law Research Paper No. 10-62

25 Pages Posted: 14 Aug 2010

See all articles by Thomas Alured Faunce

Thomas Alured Faunce

Australian National University

Timothy Vines

affiliation not provided to SSRN

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.

Suggested Citation

Faunce, Thomas Alured and Vines, Timothy, Assessing the Safety and Cost-Effectiveness of Early Nanodrugs (2009). Journal of Law and Medicine, Vol. 16, pp. 822-845, 2009; ANU College of Law Research Paper No. 10-62. Available at SSRN: https://ssrn.com/abstract=1658214

Thomas Alured Faunce (Contact Author)

Australian National University ( email )

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

Timothy Vines

affiliation not provided to SSRN

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