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FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis

OBJECTIVE: To analyze the US Food and Drug Administration (FDA) approval, trials, unmet needs, benefit, and pricing of ultra-rare (<6600 affected US citizens), rare (6600-200 000 citizens), and common (>200 000 citizens) orphan cancer drug indications and non-orphan cancer drug indications. DE...

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Detalles Bibliográficos
Autores principales: Michaeli, Thomas, Jürges, Hendrik, Michaeli, Daniel Tobias
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10167557/
https://www.ncbi.nlm.nih.gov/pubmed/37160306
http://dx.doi.org/10.1136/bmj-2022-073242