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Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?

Bernabe, RDLC; van Thiel, GJMW; Breekveldt, NS; Gispen, CC; van Delden, JJM

BMC MEDICAL ETHICS, 2020; 21 (1):

Abstract

Background: In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspect......

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