Characteristics Of Preapproval And Postapproval Studies For Drugs Granted Accelerated Approval By The US Food And Drug Administration

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

Question What are the characteristics and findings of preapproval and mandated postapproval trials of drugs granted US Food and Drug Administration (FDA) accelerated approval between 2009 and 2013?

Findings The FDA granted accelerated approval to 22 drugs for 24 indications. Clinical trials conducted before (n=30) and after (n=18) approval had similar design characteristics, such as lack of blinding, randomization, and comparator groups.

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