美国食品药品监督管理局（FDA）正积极探索利用人工智能（AI）技术来加速药物审批流程，以应对冗长的审批过程。在特朗普政府加大对自动化投资的背景下，FDA计划通过AI审查设备和药物申请，从而缩短审批时间。此外，FDA还计划采用AI计算模型来减少动物实验，并简化审批流程，例如，可能仅需一项主要患者研究即可获得批准。尽管如此，一些专业人士对这些变革持谨慎态度。文章由FDA官员撰写，强调了在平衡安全性和创新性的前提下，重新思考AI方法的重要性。

🚀 FDA 计划利用人工智能技术来审查设备和药物申请，旨在大幅缩短审批流程，从而提高效率。

🧪 FDA 计划采用AI计算模型来减少动物实验，这被视为简化审批流程的一部分，目标是加速药物的上市。

💡 FDA 计划简化审批程序，例如，可能仅需一项主要患者研究即可获得批准，以加速药物的批准过程。

🤔 尽管FDA雄心勃勃，但一些专业人士对这些变革表示怀疑，这反映了在采用新技术时，对安全性和准确性的担忧。

The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal worker layoffs.

The administration wants to “radically increase efficiency” using the burgeoning technology, according to a new article published in the Journal of the American Medical Association (JAMA) outlining the agency's priorities. The department's plan includes using artificial intelligence to examine device and drug applications, which would reportedly shave years off of the approval process, as well as AI computational modeling to reduce animal testing. The plan also proposes requiring just one major patient study to facilitate approvals, part of an overhaul of "legacy" processes.

The article cites the success of COVID-19's Operation Warp Speed as precedent for diminished release timelines, but many professionals remain skeptical. "Rethinking our approach to AI, balancing safety and accuracy while fueling innovation, is a leading FDA priority... The FDA and our great medical profession should unite to consider fresh new approaches to the evolving health topics facing the US today." the report reads. "The FDA will take conflict of interest seriously."

The article was authored by Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), and Commissioner of Food and Drugs Martin A. Makary. Prasad and Makary have backed the department overhaul touted by U.S. Secretary of Health and Human Services Robert F. Kennedy, Jr. Kennedy has been on the offensive against the nation's scientists and physicians, labelling the FDA "a sock puppet of industry," clearing the Centers for Disease Control and Prevention (CDC)'s vaccine advisory committee, and pushing for a generative AI overhaul.

In May, the FDA launched its first AI-assisted scientific review pilot, intended to "reduce the amount of non-productive busywork" for FDA scientists and subject matter experts, according to Makary. That same month, experts admonished a report by Kennedy's Make America Healthy Again initiative that was allegedly riddled with fake studies and incorrect citations possibly produced by artificial intelligence.