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...

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Detalles Bibliográficos
Autores principales: Mitra-Majumdar, Mayookha, Powers, John H, Brown, Beatrice L, Kesselheim, Aaron S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Research
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

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