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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...

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Detalles Bibliográficos
Autores principales: Vitry, Agnes, Nguyen, Tuan, Entwistle, Vikky, Roughead, Elizabeth
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
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