林业发展局于2026年2月1日启动了预先检查,以加快药物设施审批速度,但7种快车道药物中有4种由于安全问题而出现延误。 The FDA launched PreCheck on Feb. 1, 2026, to speed drug facility approvals, but four of seven fast-tracked drugs faced delays due to safety issues.

美国FDA于2026年2月1日启动了PreCheck试点计划,以加快新国内制药设施的建设和监管审查,优先考虑关键药物和创新设计. The U.S. FDA launched the PreCheck pilot program on February 1, 2026, to accelerate construction and regulatory review of new domestic pharmaceutical facilities, prioritizing critical drugs and innovative designs. 这种两阶段的方法包括FDA在计划期间的早期参与和申请前的反,以简化批准. The two-phase approach includes early FDA engagement during planning and pre-application feedback to streamline approvals. 作为补充,《国家优先券方案》在一至两个月内就关键药物作出快速审查决定。 Complementing it, the National Priority Voucher Program offers expedited reviews—targeting decisions in one to two months—for vital drugs. 然而,内部文件显示,7种快车道药物中至少有4种由于安全和功效方面的关切而面临延误,包括病人死亡,尽管有初步时限,但一些批准仍被推迟。 However, internal documents show at least four of seven fast-tracked drugs faced delays due to safety and efficacy concerns, including a patient death, with some approvals postponed despite initial timelines. 美国食品药品管理局继续致力于在严格的安全评估中平衡速度. The FDA maintains its commitment to balancing speed with rigorous safety evaluation.