PDF(Sci-hub)
Abstract：
New regulatory guidance documents from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recently been finalized or are in draft format outlining new pathways for preclinical safety testing. The US and the European Union appear to be moving in a similar direction focussing and refining preclinical safety data requirements for both radiodiagnostics and radiotherapeutics. We here summarize these recent documents from both the US and European perspective.
摘要：
来自美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）的新的监管指导文件最近已经定稿，或以草案格式概述了临床前安全性测试的新途径。美国和欧盟似乎正在朝着类似的方向发展，以集中和完善放射诊断和放射治疗的临床前安全数据要求。我们在这里从美国和欧洲的角度总结了这些最近的文件。
