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Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation

This study used the Drugs@FDA database to review FDA-approved “breakthrough” therapies from 2012 to 2017 (characterizing the pivotal clinical trials that serve as the basis of FDA approval), and premarket development and review times to assess the strength of evidence supporting breakthrough approva...

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Bibliografische gegevens
Gepubliceerd in:JAMA
Hoofdauteurs: Puthumana, Jeremy, Wallach, Joshua D., Ross, Joseph S.
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: American Medical Association 2018
Onderwerpen:
Online toegang:https://ncbi.nlm.nih.gov/pmc/articles/PMC6583484/
https://ncbi.nlm.nih.gov/pubmed/30027239
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.2018.7619
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