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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Bibliographische Detailangaben
Veröffentlicht in:JAMA
Hauptverfasser: Puthumana, Jeremy, Wallach, Joshua D., Ross, Joseph S.
Format: Artigo
Sprache:Inglês
Veröffentlicht: American Medical Association 2018
Schlagworte:
Research Letter
Online Zugang: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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