The US Food and Drug Administration (FDA) is tasked with determining whether investigational drugs are safe and effective, and with approving new drugs quickly enough for patients in need. To meet both objectives, the FDA must strike a balance between speed and safety. An excessively slow approval process may lead to lives lost among those who could have benefited from safe and effective drugs brought to market sooner. However, rapid approvals risk adverse events, including deaths. To strike a balance between inherent trade-offs in drug approval, the FDA ought to be managing risk, not minimizing it.

中文翻译：

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药品审批的速度和安全性之间的权衡

美国食品药品监督管理局（FDA）的任务是确定试验用药物是否安全有效，并迅速批准有需要的患者使用的新药。为了达到这两个目标，FDA必须在速度和安全性之间取得平衡。审批流程过慢可能会导致那些可能早日从安全有效的药物中受益的人丧生。但是，快速批准可能会带来不利事件，包括死亡。为了在药物批准的内在取舍之间取得平衡，FDA应该管理风险，而不是将其最小化。