Results for 'off-label'

998 found
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  1.  10
    Off-Label Prescribing: A Call for Heightened Professional and Government Oversight.Rebecca Dresser & Joel Frader - 2009 - Journal of Law, Medicine and Ethics 37 (3):476-486.
    Off-label prescribing is an integral part of contemporary medicine. Many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the Food and Drug Administration. An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem. In oncology, pediatrics, geriatrics, obstetrics, and other practice areas, patient care could not proceed without off-label prescribing. When scientific and medical (...)
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  2.  24
    Off-Label Prescribing: A Call for Heightened Professional and Government Oversight.Rebecca Dresser & Joel Frader - 2009 - Journal of Law, Medicine and Ethics 37 (3):476-486.
    Under current U.S. law, physicians may prescribe drugs and devices in situations not covered on the label approved by the Food and Drug Administration. Those supporting this system say that requiring FDA approval for off-label uses would unnecessarily impede the delivery of benefits to patients. Patients do benefit from off-label prescribing that is supported by sound scientific and medical evidence. In the absence of such evidence, however, off-label prescribing can expose patients to risky and ineffective treatments. (...)
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  3.  18
    Pediatric Off‐Label Use of Covid‐19 Vaccines: Ethical and Legal Considerations.Elizabeth Lanphier & Shannon Fyfe - 2021 - Hastings Center Report 51 (6):27-32.
    Can Covid-19 vaccines be used off-label? Should they be? These were questions on the minds of parents, pediatricians, and the media when the FDA fully approved the Pfizer-BioNTech Covid-19 vaccine for people aged 16 and up. Yet the American Academy of Pediatrics cautioned against pediatric off-label use of the vaccine, and the CDC Covid-19 Vaccine Provider Agreement appears to prohibit it. After briefly contextualizing ethical and legal precedents regarding off-label use, we offer an analysis of the ethical (...)
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  4.  80
    Is Off-label repeat prescription of ketamine as a rapid antidepressant safe? Controversies, ethical concerns, and legal implications.Melvyn W. Zhang, Keith M. Harris & Roger C. Ho - 2016 - BMC Medical Ethics 17 (1):1-8.
    BackgroundDepressive disorders are a common form of psychiatric illness and cause significant disability. Regulation authorities, the medical profession and the public require high safety standards for antidepressants to protect vulnerable psychiatric patients. Ketamine is a dissociative anaesthetic and a derivative of a hallucinogen. Its abuse is a major worldwide public health problem. Ketamine is a scheduled drug and its usage is restricted due to its abuse liability. Recent clinical trials have reported that ketamine use led to rapid antidepressant effects in (...)
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  5. Off-Label Prescription of COVID-19 Vaccines in Children: Clinical, Ethical, and Legal Issues.Govind Persad, Holly Fernandez Lynch & Patricia J. Zettler - 2021 - Pediatrics 2021:e2021054578.
    We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.
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  6.  20
    Off-Label Drug Use as a Consent and Health Regulation Issue in New Zealand.Rebecca Julia Cook - 2015 - Journal of Bioethical Inquiry 12 (2):251-258.
    The term “off-label drug use” refers to drugs that have not yet acquired “approved” status or drugs that have acquired “approved” status but are used with a different dosage, route, or administration method other than that for which the drug has been approved. In New Zealand, the Medicines Act 1981 specifically allows for off-label drug use. However, this authority is limited by the Health and Disability Commissioner Regulations 1996 and the common law, which require that off-label drug (...)
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  7.  11
    Off-label use of bevacizumab in the treatment of retinal disease: ethical implications.Landon James Rohowetz - 2019 - Journal of Medical Ethics 45 (10):668-672.
    Anti-vascular endothelial growth factor therapy has revolutionised the treatment of a variety of ophthalmic conditions and has become the first-line therapy for a range of retinal diseases. Bevacizumab, a VEGF inhibitor first approved for the treatment of colorectal cancer, has been shown to be nearly or virtually as effective and safe as other anti-VEGF therapies in the treatment of certain retinal diseases but is not approved or registered by the Food and Drug Administration or European Medicines Agency. While other anti-VEGF (...)
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  8.  14
    Off-label administration of drugs to healthy military personnel. Dubious ethics of preventive measures.D. O. E. Gebhardt - 2005 - Journal of Medical Ethics 31 (5):268-268.
    Although there are exceptions, the principle of primum nil nocere remains the cornerstone of the practice of medicine. In the well known handbook, Goodman and Gilman’s The Pharmacological Basis of Therapeutics1 a case is presented which raises doubts about the permissibility of off-label administration of certain drugs to healthy troops as a preventive measure. The following citation from this handbook gives a clear description of the problem:"Prophylaxis in cholinesterase inhibitor poisoning. Studies in experimental animals have shown that pretreatment with (...)
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  9.  26
    Speaking Off Label.Stephen R. Latham - 2010 - Hastings Center Report 40 (6):9-10.
    In the United States, while it is legal for physicians to prescribe drugs for “off-label” indications (uses for which the drugs do not have Food and Drug Administration approval), it is largely—though not entirely—illegal for drug manufacturers to promote off-label uses of their drugs to physicians. In recent months, the rules against off-label marketing have been rigorously enforced: in October, Allergan reached a $375 million settlement over off-label promotion of Botox; in September, Novartis settled an off- (...) marketing dispute for $422.5 million, and Forest Laboratories settled one for $313 million. These were only the latest in a series of criminal and civil settlements on off-label promotion, the most .. (shrink)
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  10.  19
    Ethische Aspekte des Off-Label-Use.Bert Heinrichs, Christina Pinsdorf & Thea Staab - 2017 - Jahrbuch für Wissenschaft Und Ethik 21 (1):47-68..
    Unter Off-Label-Use versteht man den zulassungsüberschreitenden Einsatz eines Arzneimittels außerhalb der von Zulassungsbehörden genehmigten Anwendungsgebiete. Er ist in der medizinischen Praxis weit verbreitet und fächerübergreifend zu beobachten. Der Beitrag gibt eine Einschätzung der Off-Label-Anwendung aus ethischer Sicht. Dazu wird die Off- Label-Anwendung zunächst von anderen, sachlich verwandten Anwendungsweisen abgegrenzt. Danach wird über die aktuelle Verbreitung des Off-Label- Use informiert. Sodann wird gezeigt, dass sich bekannte Problemlagen aus der Medizinethik bei der Off-Label-Anwendung in spezifischer Weise verschärfen. (...)
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  11.  12
    Marketing off-label uses to physicians: Fda's draft (mis)guidance.Andy Gass & Jennifer Wilson - 2008 - American Journal of Bioethics 8 (3):1 – 3.
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  12.  40
    The curious case of off-label use.Rebecca Dresser - 2007 - Hastings Center Report 37 (3):9-11.
  13.  15
    Research Moratoria and Off-Label Use of Ketamine.Andrea Segal & Dominic Sisti - 2016 - American Journal of Bioethics 16 (4):60-61.
    We wish to point out an additional consequence of the Catch-22 described by Andreae and colleagues (Andreae et al. 2016). The decades-long research gridlock of controlled drugs has unintentionally...
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  14.  29
    Preapproval Nontrial Access and Off-Label Use: Do They Meet Criteria for Dual-Deviation Review?Carolyn Riley Chapman, Kelly McBride Folkers, Andrew McFadyen, Lesha D. Shah & Alison Bateman-House - 2019 - American Journal of Bioethics 19 (6):22-25.
    Volume 19, Issue 6, June 2019, Page 22-25.
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  15.  14
    Should careproviders go ethically "off label"?Edmund G. Howe - 2008 - Journal of Clinical Ethics 20 (4):291-298.
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  16. policy and politics: Speaking Off Label.Stephen R. Latham - forthcoming - Hastings Center Report.
  17.  21
    Rooting Out Institutional Corruption to Manage Inappropriate Off-Label Drug Use.Marc A. Rodwin - 2013 - Journal of Law, Medicine and Ethics 41 (3):654-664.
    The Food and Drug Administration authorizes the marketing of a drug only for uses that the manufacturer has demonstrated to be safe and effective, based on evidence from at least two clinical trials. However, the FDA does not regulate the practice of medicine, so physicians may prescribe drugs in any manner they choose. Prescribing drugs in ways that deviate from the uses specified in the FDA-approved drug label, package insert, and marketing authorization is referred to as off-label prescribing. (...)
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  18.  30
    Rooting Out Institutional Corruption to Manage Inappropriate Off‐Label Drug Use.Marc A. Rodwin - 2013 - Journal of Law, Medicine and Ethics 41 (3):654-664.
    Prescribing drugs for uses that the FDA has not approved — off-label drug use — can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy (...)
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  19.  13
    Ethical Considerations for Clinical Research and Off-label Use of Ketamine to Treat Mood Disorders: The Balance Between Risks and Benefits.Roger C. Ho & Melvyn W. Zhang - 2017 - Ethics and Behavior 27 (8):681-699.
    Previous research conducted in 1999 highlighted ethical concerns behind challenge studies inducing psychosis with ketamine and made recommendations to enhance ethical standards. Recently, a plethora of clinical trials have evaluated the efficacy of ketamine to treat mood disorders, which lead to complex ethical issues. Pharmaceutical companies and researchers hope to profit by developing patentable variations on ketamine for treating depression. Media have labeled ketamine as a “miracle” antidepressant. Some clinics offer expensive off-label use of ketamine to treat mood disorders. (...)
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  20.  18
    Ethical dimensions in randomized trials and off-label use of investigational drugs for COVID-19 treatment.Pooja Dhupkar & Seema Mukherjee - 2022 - Clinical Ethics 17 (1):95-104.
    Coronavirus disease 2019 is a fast-developing viral pandemic spreading across the globe. Due to lack of availability of proven medicines against COVID-19, physicians have resorted to treatments through large trials of investigational drugs with poor evidence or those used for similar diseases. Large trials randomize 100–500+ patients at multiple hospitals in different countries to either receive these drugs or standard treatment. In order to expedite the process, some regulatory agencies had also given permission to use drugs approved for other diseases, (...)
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  21.  15
    Ethical Considerations Regarding Disclosure of Off-Label Drug and Device Use as a Component of Informed Consent in a Resident Training Program.Jordan Fakhoury, Adam Bitterman, Christopher Healy, Michael Grosso & James Gurtowski - 2016 - Ethics in Biology, Engineering and Medicine 7 (1-2):1-10.
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  22.  25
    When Are Medical Apps Medical? Off-Label Use and the Food and Drug Administration.William H. Krieger - unknown
    People have a love/hate relationship with rapidly changing healthcare technology. While consumer demand for medical apps continues to grow as rapidly as does supply, healthcare professionals and safety experts worry about the impact of these apps on the health consumer. In response to the rapidly growing mobile healthcare sector, the Food and Drug Administration has put forth guidelines to regulate ‘mobile medical apps’, those health-related apps that are designated as medical devices. In this article, I argue that this decision, to (...)
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  23.  18
    Comment on: the influence of the pharmaceutical industry on the off-label use of its medicines.A. Herxheimer - 2002 - Journal of Medical Ethics 28 (4):277-a-277.
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  24.  17
    The Relevance of Research Study Phase to Disclosure of Off-Label Drug Availability.Amrutha Baskaran & Robert M. Sade - 2014 - American Journal of Bioethics 14 (4):53-54.
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  25.  36
    The influence of the pharmaceutical industry on the off-label use of its medicines.D. O. E. Gebhardt - 2002 - Journal of Medical Ethics 28 (4):277-277.
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  26.  22
    Tun oder Unterlassen: Medikamentenverordnung im „Off-label use“ innerhalb der Grenzen der Erstattungsfähigkeit am Beispiel des Restless-legs-Syndroms.Henriette Krug - 2005 - Ethik in der Medizin 17 (2):159-163.
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  27.  45
    The Ethics of Disclosing to Research Subjects the Availability of Off-Label Marketed Drugs.Holly A. Taylor, Ellen Kuwana & Benjamin S. Wilfond - 2014 - American Journal of Bioethics 14 (4):51-51.
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  28.  11
    Researchers Have an Ethical Obligation to Disclose the Availability of Off-Label Marketed Drugs.Tomas J. Silber - 2014 - American Journal of Bioethics 14 (4):52-52.
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  29.  15
    Capital Report: No Fountain of Youth: FDA and NIH Review Off-Label Use of Hormones.Kathi E. Hanna - 2003 - Hastings Center Report 33 (4):8.
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  30.  4
    Capital Report: No Fountain of Youth: FDA and NIH Review Off-Label Use of Hormones.Kathi E. Hanna - 2003 - Hastings Center Report 33 (4):8.
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  31. Co-cognition and off-line simulation: Two ways of understanding the simulation approach.Jane Heal - 1998 - Mind and Language 13 (4):477-498.
    It is generally assumed that the debate between theory‐theory and simulation theory is an empirical one, but this view of the structure of the debate is misleading. It is an a priori truth that theory‐theory is mistaken and equally a priori that simulation in one sense (here labelled ‘co‐cognition’) is central in thinking about the thoughts of others. Given this, it is a further question how our co‐cognitive powers are realized in sub‐personal machinery. Here simulation in quite another sense (that (...)
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  32.  20
    Off-Center: Considering Directional Valences in Norse Cosmography.Kevin J. Wanner - 2009 - Speculum 84 (1):36-72.
    In this article I offer an account and analysis of several patterns of valuation of the cardinal directions in medieval Scandinavian texts. While my topic is not altogether novel—ideas about space, along with those of time, have been matters of widespread and perennial concern to scholars of culture and religion, and those interested in the Norse context have proven no exception—I seek to go beyond previous examinations in several ways. First, many of the scholars who have focused on directionality in (...)
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  33.  15
    The Ethics of Menu Labelling.Stacy M. Carter - 2015 - Public Health Ethics 8 (1):94-97.
    In this commentary, I explore the ethically relevant dimensions of menu labelling. The evidence that menu labelling changes purchasing or consumption behaviour is contentious and inconclusive; there is some suggestion that menu labelling may preferentially influence the behaviour of healthier and wealthier citizens. Some suggest that menu labelling is unjust, as it fails to direct resources towards those who most need them. An alternative is to see menu labels as just one of a set of strategies that can increase people’s (...)
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  34.  34
    Supermarket power, own-labels, and manufacturer counterstrategies: international relations of cooperation and competition in the fruit canning industry. [REVIEW]Libby Hattersley, Bronwyn Isaacs & David Burch - 2013 - Agriculture and Human Values 30 (2):225-233.
    Growing supermarket dominance and the expansion of own-label market share in Australia has put considerable pressure on agri-food manufacturers, and the recent movement of a number of manufacturing operations off-shore has attracted widespread attention. This paper examines the pursuit of an international manufacturing base by SPC Ardmona, one of Australia’s major fruit and vegetable processors, with a focus on strategic alliances formed with Siam Foods in Thailand and Rhodes Food Group in South Africa/Swaziland. Strategic horizontal alliances have become increasingly (...)
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  35.  78
    What Does Society Owe Me If I Am Responsible for Being Worse Off?Martin Marchman Andersen - 2014 - Journal of Applied Philosophy 31 (3):271-286.
    Luck egalitarians need to address the question of cost-responsibility: If an individual is responsible for being worse off than others, then what benefits, if any, is that individual uniquely cost-responsible for? By applying luck egalitarianism to justice in health I discuss different answers to this question inspired by two different interpretations of luck egalitarianism, namely ‘standard luck egalitarianism’ and ‘all luck egalitarianism’, respectively. Even though I argue that the latter is more plausible than the former, I ultimately suggest and defend (...)
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  36.  1
    L'écart absolu: Miguel Abensour.Gilles Labelle - 2018 - Paris (France): Sens&Tonka.
  37.  2
    Vers une démocratie désenchantée?: Marcel Gauchet et la crise contemporaine de la démocratie libérale.Gilles Labelle & Daniel Tanguay (eds.) - 2013 - [Anjou, Québec]: Fides.
    Il y a un peu plus de vingt ans, Marcel Gauchet livrait ses réflexions sur le long et lent processus de désenchantement du monde qui, de l’intérieur même de la compréhension religieuse du monde, a abouti à l’affirmation de l’autonomie humaine et à la prise en main par les hommes de leur destin collectif. Cette thèse a fait l’objet de nombreuses discussions et controverses qui portaient sur la validité de la reconstruction historique générale, sur la méthode guidant cette dernière, et (...)
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  38.  11
    Acoustic justice: listening, performativity, and the work of reorientation.Brandon LaBelle - 2021 - New York City: Bloomsbury Academic.
    Authored by leading sound studies scholar Brandon LaBelle, this book focuses on questions of acoustics as the basis for challenging normative structures.
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  39.  17
    Family Firms’ Corporate Social Performance: A Calculated Quest for Socioemotional Wealth.Réal Labelle, Taïeb Hafsi, Claude Francoeur & Walid Ben Amar - 2018 - Journal of Business Ethics 148 (3):511-525.
    This study investigates the engagement of family firms in corporate social responsibility. We first compare their corporate social performance to non-family firms. Then, following recent evidence on the heterogeneity of family firms, we examine two factors that may influence CSP within family firms: the level of family control and the governance orientation of the country in which they operate. This research is based on a theoretical framework which considers both agency and socioemotional wealth influences on family firms CSR engagements. Overall, (...)
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  40. Ethics, Diversity Management, and Financial Reporting Quality.Réal Labelle, Rim Makni Gargouri & Claude Francoeur - 2010 - Journal of Business Ethics 93 (2):335-353.
    This article proposes and empirically tests a theoretical framework incorporating Reidenbach and Robin’s (J Bus Ethics 10(4):273–284, 1991 ) conceptual model of corporate moral development. The framework is used to examine the relation between governance and business ethics, as proxied by diversity management (DM), and financial reporting quality, as proxied by the magnitude of earnings management (EM). The level of DM and governance quality are measured in accordance with the ratings of Jantzi Research (JR), a leading provider of social and (...)
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  41.  4
    Strukturprobleme des kapitalistischen Staates.Claus Offe - 1972 - Frankfurt am Main]: Suhrkamp.
  42. Contradictions of the Welfare State.Claus Offe - 1984 - MIT Press.
    Contradictions of the Welfare State is the first collection of Offe's essays to appear in a single volume in English, and it contains a selection of his most important recent work on the breakdown of the post-war settlement.
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  43. Disorganized Capitalism: Contemporary Transformations of Work and Politics.Claus Offe - 1985 - Cambridge: MIT Press.
    Should the Western democracies, contrary to their prevailing self-image as "planned" and "managed," be seen as highly disorganized systems of social power and political authority? If so, what are the symptoms, consequences of, and possible remedies for these disorganizing tendencies?In these ten essays, Claus Offe seeks to answer such questions. Moving beyond the boundaries of both Marxism and established forms of political sociology, he focuses on the growth of serious divisions within the work force, the importance of the "informal" sector, (...)
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  44.  60
    Two refoundation projects of democracy in contemporary French philosophy: Cornelius Castoriadis and Jacques Rancière.Gilles Labelle - 2001 - Philosophy and Social Criticism 27 (4):75-103.
    In this paper I examine two theories of democracy that can be found in contemporary French philosophy. Both Cornelius Castoriadis and Jacques Rancière offer a critique of modern democracy with the purpose of refounding it. The ‘refoundation narratives’ they propose are both based on an account of the origins of democracy in ancient Greece. According to Castoriadis, ancient democracy is grounded in a ‘magma’ of ‘social imaginary significations’ in which ‘autonomy’ is considered the correct response to Being defined as an (...)
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  45.  6
    Sonic agency: sound and emergent forms of resistance.Brandon LaBelle - 2018 - Cambridge, MA: The MIT Press.
    The book proposes a multi-dimensional understanding on sound and listening as capacities for challenging social and political structures of inequality and domination, supporting interpersonal exchange and modes of community-building based on empathy, care and compassion.
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  46. New Social Movements: Challenging the Boundaries of Institutional Politics.Claus Offe - 1985 - Social Research: An International Quarterly 52.
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  47.  23
    Modernity and the State: East, West.Claus Offe - 1996 - MIT Press.
    Modernity and the State, a dozen essays written over thelast decade, develops his earlier lines of interest and extends them to the new societies emergingin Central-Eastern Europe.Offe frames the essays by suggesting that the key question ...
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  48.  4
    Déplacement stylistique à gauche de verbes non conjugués en ancien et en moyen français.Marie Labelle & Paul Hirschbühler - 2014 - Corpus 13:191-219.
    L’antéposition d’un verbe non conjugué (participe passé, infinitif) en ancien et en moyen français a été assimilée à l’antéposition stylistique de l’islandais. Nous montrons que dans le cas du français, ces antépositions illustrent trois constructions différentes, toutes distinctes de l’antéposition stylistique de l’islandais. Dans la construction la plus fréquente, étiquetée déplacement stylistique à gauche, l’expression antéposée s’insère dans une position interne à la proposition plutôt que dans la périphérie gauche, à la droite immédiate de la position canonique du sujet, qui (...)
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  49. Governance: An "empty signifier"?Claus Offe - 2009 - Constellations 16 (4):550-562.
  50.  50
    Basic Income and the Labor Contract.Claus Offe - 2009 - Analyse & Kritik 31 (1):49-79.
    The paper starts by exploring the negative contingencies that are associated with the core institution of capitalist societies, the labour contract: unemployment, poverty, and denial of autonomy. It argues that these are the three conditions that basic income schemes can help prevent. Next, the three major normative arguments are discussed that are raised by opponents of basic income proposals: the idle should not be rewarded, the prosperous don’t need it, and there are so many things waiting to be done in (...)
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