根据一项与国家利益挂钩的新特朗普时代方案,林业发展局正在快速追踪九种药物,以便在30-60天内获得批准。
The FDA is fast-tracking nine drugs for approval in 30–60 days under a new Trump-era program tied to national interests.
林业发展局宣布,它将根据一项新的特朗普管理方案,对九种实验药物进行快速审查,优先考虑与国家利益挂钩的药物,争取在30至60天内获得批准,比通常的6至10个月快得多。
The FDA announced it will fast-track reviews of nine experimental drugs under a new Trump administration program prioritizing medicines tied to national interests, aiming for approvals in 30 to 60 days—far quicker than the typical six to ten months.
这些药物包括戒毒治疗、耳聋、胰腺癌、以及一种可注射的生育药物Pergoveris。 行政当局说,这可以降低抗逆转录病毒药物的费用。
The drugs include treatments for vaping addiction, deafness, pancreatic cancer, and an injectable fertility drug, Pergoveris, which the administration says could lower IVF costs.
该方案还寻求扩大国内氯胺酮生产,以用于精神病治疗。
The program also seeks to expand domestic ketamine production for psychiatric use.
该倡议由 FDA 专员 Marty Makary 博士领导,借鉴了曲速行动的经验教训,并在选择候选人时赋予了广泛的自由裁量权。
Led by FDA Commissioner Dr. Marty Makary, the initiative uses lessons from Operation Warp Speed and grants broad discretion in selecting candidates.
虽然仍需要安全和有效性,但专家们对透明度和潜在影响提出了关切。
While safety and effectiveness remain required, experts have raised concerns about transparency and potential influence.
包括阿尔茨海默氏抗体和血液测试在内的关键药物的决定预计将在2025年10月作出。
Decisions on key drugs, including an Alzheimer’s antibody and a blood test, are expected in October 2025.