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  1. Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?Rosemarie D. L. C. Bernabe, Ghislaine J. M. W. van Thiel, Nancy S. Breekveldt, Christine C. Gispen & Johannes J. M. van Delden - 2020 - BMC Medical Ethics 21 (1):1-8.
    Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. (...)
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  • Ethical challenges of clinical trials with a repurposed drug in outbreaks.Katarzyna Klas, Karolina Strzebonska & Marcin Waligora - 2023 - Medicine, Health Care and Philosophy 26 (2):233-241.
    Drug repurposing is a strategy of identifying new potential uses for already existing drugs. Many researchers adopted this method to identify treatment or prevention during the COVID-19 pandemic. However, despite the considerable number of repurposed drugs that were evaluated, only some of them were labeled for new indications. In this article, we present the case of amantadine, a drug commonly used in neurology that attracted new attention during the COVID-19 outbreak. This example illustrates some of the ethical challenges associated with (...)
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