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Evidence at time of regulatory approval and cost of new antibiotics in 2016-19: cohort study of FDA approved drugs
OBJECTIVE: To review the clinical evidence, regulatory background, and cost of antibiotics approved by the US Food and Drug Administration (FDA), 2016-19. DESIGN: Cohort study of FDA approved drugs. DATA SOURCES: FDA databases, ClinicalTrials.gov, and drug labelling. Launch prices were extracted fro...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9978751/ https://www.ncbi.nlm.nih.gov/pubmed/36936591 http://dx.doi.org/10.1136/bmjmed-2022-000227 |