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CLINICAL TRIAL EVIDENCE SUPPORTING FDA APPROVAL OF NOVEL THERAPEUTICS, 2005–2012
IMPORTANCE: Many patients and physicians assume that the safety and effectiveness of newly approved therapeutics is well understood; however, the strength of the clinical trial evidence supporting approval decisions by the Food and Drug Administration (FDA) has not been evaluated. OBJECTIVES: To cha...
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| Hauptverfasser: | , , , , |
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| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
2014
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| Schlagworte: | |
| Online Zugang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4144867/ https://ncbi.nlm.nih.gov/pubmed/24449315 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.2013.282034 |
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