Law of Off-label Uses of Medicines
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Law of Off-label Uses of Medicines
Regulation and Litigation in the EU, UK and USA
Parziale, Andrea
Taylor & Francis Ltd
05/2024
198
Mole
9781032079004
Pré-lançamento - envio 15 a 20 dias após a sua edição
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
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
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
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
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
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
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
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
