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JNCI Journal of the National Cancer Institute 2004 96(20):1487; doi:10.1093/jnci/96.20.1487
© 2004 by Oxford University Press
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© 2004 Oxford University Press

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FDA and Accelerated Approval of Oncology Products

The U.S. Food and Drug Administration (FDA) accelerated approval regulations allow for the approval of drugs for serious or life-threatening diseases by permitting use of a surrogate endpoint, such as objective response rate, that is reasonably likely to predict clinical benefit, such as survival or symptom benefit. The regulations stipulate, however, that approval is granted pending completion of studies designed to confirm clinical benefit, which have to be conducted with due diligence. Dagher et al. (p. 1500) review the regulatory history of the accelerated approval process, summarize the FDA . . . [Full Text of this Article]

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