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Should benefit–risk assessment have its own drug “label”?

Many consumers and clinicians incorrectly believe that the Food and Drug Administration (FDA) approval of a new therapeutic implies that its benefits have been proven to exceed its harms. While the FDA could require proof that benefits exceed harms prior to approval, it has been argued that this app...

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Detalles Bibliográficos
Autor principal: Braithwaite, R Scott
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3163936/
https://www.ncbi.nlm.nih.gov/pubmed/21904466
http://dx.doi.org/10.2147/DHPS.S21927