Differential times of submission and approval of CFTR modulators for the treatment of Cystic Fibrosis in the United States and the European Union-Reference-Cited by-同舟云学术

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Differential times of submission and approval of CFTR modulators for the treatment of Cystic Fibrosis in the United States and the European Union

Published:2024-08 Issue: Volume: Page:
ISSN:1569-1993
Container-title:Journal of Cystic Fibrosis
language:en
Short-container-title:Journal of Cystic Fibrosis

Author:

Costa Enrico^ORCID,Girotti Silvia^ORCID,Mathieu Clément^ORCID,Castellani Carlo^ORCID,Ross Joseph S.^ORCID,Taylor-Cousar Jennifer L.^ORCID,Leufkens Hubert G.M.

Publisher

Elsevier BV

Reference21 articles.

1. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study;Hwang;BMJ,2020

2. Regulatory review duration and differences in submission times of drugs in the United States and Europe, 2011 to 2020;Vokinger;Ann Intern Med,2023

3. Effect of VX-770 in persons with cystic fibrosis and the G551D-CFTR mutation;Accurso;N Engl J Med,2010

4. Projecting the impact of delayed access to elexacaftor/tezacaftor/ivacaftor for people with Cystic Fibrosis;Stanojevic;J Cyst Fibros,2021

5. Cystic fibrosis: emergence of highly effective targeted therapeutics and potential clinical implications;Mall;Am J Respir Crit Care Med,2020

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