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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 clarif...
Today, mafias operate across the globe, with hundreds of thousands of members and billions of dollars in revenue. From Hong Kong to New York, these vast organizations spread their tentacles into politics, finance and everyday life. Criminologist Federico Varese draws on a lifetime's research to give us access to some of the world's most secretive societies. Mixing reportage with case studies and historical insights, this is the story of mafia as it really is: filled with boredom and drama, death and disaster, ambition and betrayal.
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