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...

Descripción completa

Detalles Bibliográficos
Autores principales: Bernabe, Rosemarie D. L. C., van Thiel, Ghislaine J. M. W., Breekveldt, Nancy S., Gispen, Christine C., van Delden, Johannes J. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590474/
https://www.ncbi.nlm.nih.gov/pubmed/33109181
http://dx.doi.org/10.1186/s12910-020-00543-w

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7590474/
https://www.ncbi.nlm.nih.gov/pubmed/33109181
http://dx.doi.org/10.1186/s12910-020-00543-w

Ejemplares similares