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自1995年以来,美国和欧洲权威机构批准上市的生物制剂中大概有1/4在10年内收到至少一起与安全性有关的监管决策的调整。
Almost a quarter of the biologics approved by the United States and European authorities since 1995 have received at least one adjustment to safety-related regulatory decisions within 10 years.