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Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study
BACKGROUND: Withdrawal of conditional regulatory approval or subsidization of new medicines when subsequent evidence does not confirm early trial results may not be well understood or accepted by the public. OBJECTIVES: We present a case study of the US Food and Drug Administration (FDA)’s decision...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4610052/ https://www.ncbi.nlm.nih.gov/pubmed/26483954 http://dx.doi.org/10.1186/s40545-015-0046-2 |