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

Huseyin Naci | Zendy; Katelyn R. Smalley | Zendy; Aaron S. Kesselheim | Zendy

Open Access

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

Author(s) -

Huseyin Naci,

Katelyn R. Smalley,

Aaron S. Kesselheim

Publication year - 2017

Publication title -

jama

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 4.688

H-Index - 680

eISSN - 1538-3598

pISSN - 0098-7484

DOI - 10.1001/jama.2017.9415

Subject(s) - medicine , food and drug administration , clinical trial , blinding , clinical study design , medline , intensive care medicine , pharmacology , political science , law

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 whether these effects translate to clinical improvements.

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