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The Law of Off-label Uses of Medicines
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...
Architecture and the Novel under the Italian Fascist Regime
Architecture and the Novel under the Italian Fascist Regime discusses the relationship between the novel and architecture during the Fascist period in Italy (1922-1943). By looking at two profoundly diverse aesthetic phenomena within the context of the creation of a Fascist State art, Billiani and Pennacchietti argue that an effort of construction, or reconstruction, was the main driving force behind both projects: the advocated “revolution” of the novel form (realism) and that of architecture (rationalism). The book is divided into seven chapters, which in turn analyze the interconnections between the novel and architecture in theory and in practice. The first six chapters cover debates on State art, on the novel and on architecture, as well as their historical development and their unfolding in key journals of the period. The last chapter offers a detailed analysis of some important novels and buildings, which have in practice realized some of the key principles articulated in the theoretical disputes.
