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03268aam a2200373 i 4500 001 185CDBE8803411ED944134D030ECA4DB 003 SILO 005 20221220010056 008 220308t20232023enk b 001 0 eng 010 $a 2022011267 020 $a 1032079002 020 $a 9781032079004 020 $a 1032078987 020 $a 9781032078984 035 $a (OCoLC)1301485053 040 $a DLC $b eng $e rda $c DLC $d OCLCF $d YDX $d SILO 042 $a pcc 050 00 $a K3637 $b .P37 2023 100 1 $a Parziale, Andrea, $e author. 245 14 $a The law of off-label uses of medicines : $b regulation and litigation in the EU, UK, and USA / $c Andrea Parziale. 264 1 $a Abingdon, Oxon [UK] ; $b Routledge, $c 2023. 300 $a x, 198 pages ; $c 25 cm 520 $a "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 and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit's impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law"-- $c Provided by publisher. 504 $a Includes bibliographical references and index. 505 0 $a Off-label use of medicines between clinical research and practice -- The regulation of off-label uses in the EU, EU Member States, and UK -- The US regulation of off-label uses of medicines -- Litigation trends in the EU, EU Member States, and UK -- Litigation trends in the USA -- The influence of the precautionary principle in the civil litigation on off-label uses. 650 0 $a Drugs $x Law and legislation. $x Law and legislation. 650 0 $a Off-label drug use. 650 0 $a Drugs $x Law and legislation. 650 7 $a Drugs $x Law and legislation. $x Law and legislation. $2 fast $0 (OCoLC)fst00898828 650 7 $a Drugs $x Law and legislation. $2 fast $0 (OCoLC)fst00898830 650 7 $a Off-label drug use. $2 fast $0 (OCoLC)fst02009972 941 $a 1 952 $l OVUX522 $d 20230517010204.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=185CDBE8803411ED944134D030ECA4DBInitiate Another SILO Locator Search