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Medical News and Perspectives
June 25, 2003

Accelerated Approval Scrutinized

JAMA. 2003;289(24):3227-3229. doi:10.1001/jama.289.24.3227

The accelerated approval regulations of the US Food and Drug Administration (FDA) allow pharmaceutical manufacturers to offer patients treatment for life-threatening diseases. This may occur when early evidence suggests that the agent is likely to improve survival or reduce symptoms, before confirmatory studies show whether the compounds are fully safe and efficacious.

However, while this concept is embraced by many clinicians and patients, recent evidence suggests that its execution leaves much to be desired.

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