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3 月 28 日，美国 FDA 公告提交 2023 年财政预算总金额 84 亿美金，较 2022 年增加 34%。资金预计将投入于 3 大重点领域：推动流行病预防计画、食品与医疗产品安全、以及公卫现代化设施建置。
FDA 委员成员 Robert M. Califf 博士表示，FDA 将继续致力于 COVID-19 以及其他非 COVID-19 疾病防治，FDA 目前已针对当今急迫的健康需求，着手监管动物食品安全、医疗设备与电子烟安全性，将来将不断跟上科学进展并因应紧急公卫状况。
NIH、FDA 联手各大药厂，解决罕病治疗困境！（基因线上国际版）84 亿资金预计分配于 4 领域，以下分别介绍。
布建流行性疾病预防措施
为了及早预防下一次流行性疾病来袭，FDA 预计于未来 5 年内投注 16 亿，支持流行病预防计画 HHS Pandemic Preparedness Plan 发展。FDA 将透过加强 IT 与实验设备，并提升疫苗与治疗方法的评估系统，共同促进医疗进展，未来面临重大流行病或者生物性威胁得以快速采取因应措施。
推动食安与营养现代化
此部分投入资金分为两重点：推动食品安全现代化、落实健康营养平权。前者预计分配 4,300 万应用于增进动物食品安全，例如推动食安相关法案 New Era of Smarter Food Safety。FDA 也会提升数据分析能力，以提升食品风险评估与监管系统。
另一部分资金 1,400 万，则用于落实健康营养平权，例如提案立法限制食品中污染物、规范配方奶与膳食补充剂等易感族群的医疗食品安全性。
促进安全有效的医疗产品上市
FDA 将划分 6,000 万美金在医疗产品领域，预计再细分为 4 的子类别。首先，拨款 2,000 万一次投入癌症登月计划（Cancer Moonshot），并持续透过支持癌症卓越中心（Oncology Center of Excellence）发展以推动癌症治疗进展。其次，500 万用于改善医材设备的网络安全，也包含扩编资安人员。
第三，随着动物药品送件量持续增加，将投入 500 万以加速动物药品上市前的审查机制。第四，3,000 万用于改善鸦片药物滥用危机，分为 4 项推动领域：减少鸦片接触与预防成瘾、支持鸦片成瘾者的治疗计画、推动新的止痛疗法发展、改善执法和评估风险效益机制。
其他核心业务
推动数位化基础设施是 FDA 一大努力方向，FDA 将划分 6,800 万用于优化 AI、机器学习、大数据等数据分析能力。
为了减少尼古丁成瘾风险，FDA 近年加强监管电子烟与电子尼古丁传送系统（ENDS）等产品，预算中也拟拨高达 1 亿美金，扩大纳入评估相关厂商的产品成分。
最后，医药品审核与改良临床试验流程方面，将投入 2,400 万于提升医药品审核效率，以及 500 万用于开发新的临床替代方案，朝减少动物试验、更有预测性的实验方法等方向改良。
延伸阅读：FDA 公布基因编辑与 CAR-T 细胞疗法两份指南草案©www.geneonline.news. All rights reserved. 基因线上版权所有 未经授权不得转载。合作请联系：service@geneonlineasia.com
