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Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
OBJECTIVE: To characterize the therapeutic value of new drugs approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the association between these ratings and regulatory approval through expedited programs. DESIGN: Retrospective cohort study. SETTING: New drugs...
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| Veröffentlicht in: | BMJ |
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| Hauptverfasser: | , , , |
| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
BMJ Publishing Group Ltd.
2020
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| Schlagworte: | |
| Online Zugang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7537471/ https://ncbi.nlm.nih.gov/pubmed/33028575 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmj.m3434 |
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