- 270 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
About this book
This book develops a theoretical framework for examining and assessing the regulatory arrangements for medical products.
Since the first half of the 20th century, the regulation of pharmaceuticals, medical devices and, more recently, biologicals have been controlled in many jurisdictions by specific regulatory regimes and agencies. Their regulatory mandates are similar – to ensure the quality, safety and efficacy of medical products. This book provides a timely and relevant assessment of the complexities of medical regulatory regimes, by drawing on a particular theory of political legitimacy. In this respect, the book adopts a 'dialogic' approach – according to which a shared set of normative beliefs and values are formulated – as a theoretical 'tool' to identify deficiencies in the regulatory arrangements for medical products. Drawing on several Australian cases studies, characterised by divergent normative perspectives, the book develops its dialogic approach in order to challenge the usual legitimation of regulatory regimes from the perspective of science alone. Specifically, it maintains that such regimes need to embrace a normative pluralism that admits a diversity of types and sources of knowledge.
This evaluation of the increasingly influential domain of medical regulation will appeal to a range of scholars and practitioners working in law, public health, politics and science and technology studies.
Frequently asked questions
- Essential is ideal for learners and professionals who enjoy exploring a wide range of subjects. Access the Essential Library with 800,000+ trusted titles and best-sellers across business, personal growth, and the humanities. Includes unlimited reading time and Standard Read Aloud voice.
- Complete: Perfect for advanced learners and researchers needing full, unrestricted access. Unlock 1.4M+ books across hundreds of subjects, including academic and specialized titles. The Complete Plan also includes advanced features like Premium Read Aloud and Research Assistant.
Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app.
Information
Table of contents
- Cover
- Half-Title
- Series
- Title
- Copyright
- Contents
- Acknowledgements
- List of Abbreviations
- 1 Introduction
- 2 The Foundations of the Regulation of Medical Products
- 3 A Constant Dialogic Approach to Political Legitimacy
- 4 Voices of Change: Regulatory Reform of Medicinal Cannabis in Australia
- 5 A Normative Void: The Regulation of Medical Abortion in Australia
- 6 Shouting to Be Heard: The Regulation of Urogynaecological Mesh Devices in Australia
- 7 Regulatory Challenges, Courage and Evolution
- 8 Conclusion
- Appendix 1: Chronology of Key Events Relating to Urogynaecological Mesh Devices (‘UMDs’)
- Bibliography
- Index