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  1. Ethics Framework for Treatment Use of Investigational Drugs.Jan Borysowski & Andrzej Górski - 2020 - BMC Medical Ethics 21 (1):1-10.
    Background Expanded access is the use of investigational drugs outside of clinical trials. Generally it is performed in patients with serious and life-threatening diseases who cannot be treated satisfactorily with authorized drugs. Legal regulations of expanded access to IDs have been introduced among others in the USA, the European Union, Canada and Australia. In addition, in the USA an alternative to expanded access is treatment under the Right-to-Try law. However, the treatment use of IDs is inherently associated with a number (...)
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  • Considerations for Applying Bioethics Norms to a Biopharmaceutical Industry Setting.Wendell Fortson, Kathleen Novak Stern, Curtis Chang, Angela Rossetti, Ariella Kelman, Michael Turik, Donald G. Therasse, Tatjana Poplazarova & Luann E. Van Campen - 2021 - BMC Medical Ethics 22 (1).
    BackgroundThe biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.Main textAny institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that (...)
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  • Different Ways to Argue About Medical Ethics.John R. McMillan - 2018 - Journal of Medical Ethics 44 (11):727-728.
    Clarifying the meaning of ethical concepts is fundamental for medical ethics. Many of the best papers in the Journal of Medical Ethics have advanced our understanding of the limits and implications of ethical concepts. This issue includes a number of papers that give us reason to reflect on the use, implications and grounding of some important ethical concepts. The concepts we use are rarely neutral. For example, those arguing against assisted dying are more likely to use terms such as ‘euthanasia’ (...)
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  • Ethically Allocating COVID-19 Drugs Via Pre-Approval Access and Emergency Use Authorization.Jamie Webb, Lesha D. Shah & Holly Fernandez Lynch - 2020 - American Journal of Bioethics 20 (9):4-17.
    Allocating access to unapproved COVID-19 drugs available via Pre-Approval Access pathways or Emergency Use Authorization raises unique challenges at the intersection of clinical care and research....
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