The Law of Off-label Uses of Medicines

This book examines the regulatory framework for untested and unapproved (off-label) uses of medicines in the EU, UK and USA. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. This work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions.

Andrea Parziale is a Marie Sk-odowska-Curie Fellow at the Institute for Transnational Legal Research at the Faculty of Law, Maastricht University

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