Information Transparency in the Drug Approval Process

To the Editor Drs Gyawali and Goldstein recently published a Viewpoint in which they accuse the US Food and Drug Administration's (FDA's) Oncologic Drugs Advisory Committee (ODAC) of being ignorant of overall survival (OS) data from the S-TRAC adjuvant sunitinib trial, and that this ignorance led to a recommendation for approval from 6 ODAC members and subsequently the FDA. They further accuse the sponsor of hiding the OS data in the Supplement of the full publication.

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