Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements? A Critical Analysis of Physicians' Argumentation for Initial Efficacy Requirements.
The amended Food, Drug and Cosmetics Act requires efficacy certification for a drug's initial uses (“on-label”), but does not require certification before physicians may prescribe the drug for subsequent uses (“off-label”). Does it make sense to require FDA efficacy certification for new drugs but n...
| Publicado en: | American Journal of Economics & Sociology Vol. 67; no. 5; pp. 743 - 776 |
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| Autores principales: | , |
| Formato: | Artículo |
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Wiley-Blackwell
November 2008
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| Acceso en línea: | Ver este registro en EBSCOhost |