Law of Off-label Uses of Medicines

Law of Off-label Uses of Medicines

Regulation and Litigation in the EU, UK and USA

Parziale, Andrea

Taylor & Francis Ltd

08/2022

198

Dura

Inglês

9781032078984

15 a 20 dias

453

Descrição não disponível.
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
Off-label uses;Compassionate uses;Torts;Product liability;Causation;Pharmaceutical Law;Health Law;Risk regulation;Precautionary principle;Clinical Practice;Civil Liability;Medicinal Products;EU Law;Civil Liability Rules;Pharmaceutical Regulation;EU Member States;UK Court;Development Risk Defence;Pharmacovigilance System;Marketing Authorisation;Medical Liability;EU's Court;PRAC;post-Brexit UK;EU Case Law;TFEU;Products Liability;Non-interventional Studies;AIFA;Daubert Test;IRB;Institutional Review Boards;EU Institution