The impact of FDA and EMA regulatory decision-making process on the access to CFTR modulators for the treatment of cystic fibrosis

BACKGROUND: Over the past decade, a new class of drugs called CFTR (cystic fibrosis transmembrane conductance regulator) modulators have shown to be able to improve clinical outcomes in patient with Cystic Fibrosis. In this analysis, we have extensively reviewed the regulatory pathways and decisions...

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Detalles Bibliográficos
Autores principales: Costa, Enrico, Girotti, Silvia, Pauro, Francesca, Leufkens, Hubert G. M., Cipolli, Marco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9078013/
https://www.ncbi.nlm.nih.gov/pubmed/35525974
http://dx.doi.org/10.1186/s13023-022-02350-5

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9078013/
https://www.ncbi.nlm.nih.gov/pubmed/35525974
http://dx.doi.org/10.1186/s13023-022-02350-5

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