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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Dades bibliogràfiques
Publicat a:JAMA
Autors principals: Naci, Huseyin, Smalley, Katelyn R., Kesselheim, Aaron S.
Format: Artigo
Idioma:Inglês
Publicat: American Medical Association 2017
Matèries:
Original Investigation
Accés en línia: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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