Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

IMPORTANCE: Drugs treating serious or life-threatening conditions can receive US Food and Drug Administration (FDA) accelerated approval based on showing an effect in surrogate measures that are only reasonably likely to predict clinical benefit. Confirmatory trials are then required to determine wh...

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Detalhes bibliográficos
Publicado no:JAMA
Main Authors: Naci, Huseyin, Smalley, Katelyn R., Kesselheim, Aaron S.
Formato: Artigo
Idioma:Inglês
Publicado em: American Medical Association 2017
Assuntos:
Original Investigation
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5817559/
https://ncbi.nlm.nih.gov/pubmed/28810023
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jama.2017.9415
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