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

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...

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Detalhes bibliográficos
Publicado no:BMC Med Ethics
Main Authors: Bernabe, Rosemarie D. L. C., van Thiel, Ghislaine J. M. W., Breekveldt, Nancy S., Gispen, Christine C., van Delden, Johannes J. M.
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2020
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7590474/
https://ncbi.nlm.nih.gov/pubmed/33109181
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s12910-020-00543-w
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