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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Vydáno v:JAMA
Hlavní autoři: Naci, Huseyin, Smalley, Katelyn R., Kesselheim, Aaron S.
Médium: Artigo
Jazyk:Inglês
Vydáno: American Medical Association 2017
Témata:
Original Investigation
On-line přístup: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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