1st Edition
The Law of Off-label Uses of Medicines Regulation and Litigation in the EU, UK and USA
By Andrea Parziale
Copyright 2023
208 Pages
by
Routledge
208 Pages
by
Routledge
208 Pages
by
Routledge
Also available as eBook on:
This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases... Read more
Preface and acknowledgements
Introduction
1. Off-label uses of medicines between clinical research and practice
2. The regulation of off-label uses in the EU, EU Member States and UK
3. The US regulation of off-label uses of medicines
4. Litigation trends in the EU, EU Member States and UK
5. Litigation trends in the US
6. The influence of the precautionary principle in the civil litigation on off-label uses
7. Conclusions
Index
Biography
Andrea Parziale is a Marie Skłodowska-Curie Fellow at the Institute for Transnational Legal Research at the Faculty of Law, Maastricht University
