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FDA’s Benefit–Risk Framework for Human Drugs and Biologics: Role in Benefit–Risk Assessment and Analysis of Use for Drug Approvals
BACKGROUND: Structured, descriptive approaches are utilized by drug regulatory agencies to support and communicate approval decisions about human drugs and biologics. The US Food and Drug Administration (FDA) uses the Benefit–Risk Framework (BRF), which has been integrated into its drug review proce...
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| Veröffentlicht in: | Ther Innov Regul Sci |
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| Hauptverfasser: | , , |
| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
2020
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| Schlagworte: | |
| Online Zugang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7785646/ https://ncbi.nlm.nih.gov/pubmed/32779045 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s43441-020-00203-6 |
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