A comparison of the Food and Drug Administration’s and Health Canada’s regulatory decisions about failed confirmatory trials for oncology drugs: an observational study

BACKGROUND: Oncology drugs are frequently approved on the basis of surrogate outcomes that require further trials to confirm the benefits, but at times these trials fail and regulators need to decide whether to withdraw approval for the indication and/or to remove the drug from the market. This stud...

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Detalles Bibliográficos
Autor principal: Lexchin, Joel
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8555114/
https://www.ncbi.nlm.nih.gov/pubmed/34711285
http://dx.doi.org/10.1186/s40545-021-00375-y

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8555114/
https://www.ncbi.nlm.nih.gov/pubmed/34711285
http://dx.doi.org/10.1186/s40545-021-00375-y

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