（通讯员 韩剑报道）为从源头拧紧口腔诊所药械质量安全阀，新疆沙湾市市监局主动靠前发力，精准 聚焦仅取得营业执照、尚未完成医疗机构备案、且未购进药品医疗器械的新开办口腔诊所，把监管服务 送到"起跑线"上，从起步阶段帮诊所夯实药械质量安全管理基础。执法人员将服务关口前移，围绕口腔 诊所常用的定制式义齿、牙科种植体、正畸材料、消毒器械等核心器械，逐项讲解药械采购验收、储存 养护、台账记录等关键环节，现场演示核验供货商资质、产品注册证等材料的核验流程，确保药械来源 可溯，去向可追。同时，执法人员送上"普法大礼包"，结合典型案例解读违规使用药械的法律后果，以 案说法敲警钟，提醒诊所树立"合规先行"的经营理念，守牢药械使用安全底线。 此次前置监管，新疆沙湾市市监局变"事后处罚"为"事前帮扶"，即为新开办口腔诊所筑牢药械使用安全 防线，也让市场主体感受到了监管的"力度"与"温度"。下一步，新疆沙湾市市监局将持续深化"放管 服"，把前置指导服务延伸到更多医疗相关邻域，用精准监管和暖心服务，守牢群众就医用药用械质量 安全。 ...

Core Viewpoint - The FDA is implementing a comprehensive generative AI system across its organization by June 2025, marking a significant shift towards regulatory intelligence and efficiency in drug review processes [3][4][21]. Group 1: FDA's AI Implementation - The FDA's Director, Martin Makary, announced that all regulatory centers must fully integrate the generative AI system by June 30, 2025, to assist in various review tasks, significantly improving efficiency [3][4]. - This initiative is led by the newly appointed Chief AI Officer, Jeremy Walsh, who aims to create a unified, secure AI system embedded within the FDA's data platform, moving beyond simple AI tools to a more integrated operational model [4][9]. - The FDA's previous pilot projects demonstrated that AI could drastically reduce review times, with one expert noting that tasks that took three days could now be completed in minutes [3][8]. Group 2: Historical Context and Strategic Direction - The FDA's journey with AI began in 2021 with the "Digital Health Technologies Plan," which aimed to incorporate AI/ML into its regulatory modernization strategy [6][8]. - In January 2023, the FDA released the "Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan," transitioning AI from an evaluation subject to an internal capability to enhance review efficiency [6][8]. Group 3: Global Comparison and Regulatory Landscape - The FDA is the first major regulatory body to set a clear timeline for a comprehensive AI rollout, supported by its long-term data governance and modernization efforts [12][18]. - Other global regulatory bodies, such as the EMA and Japan's PMDA, are still in exploratory phases, focusing on ethical considerations and small-scale trials, while China's NMPA has made significant progress in AI medical device approvals but is still in early stages of integrating AI into internal processes [16][19]. Group 4: Implications for the Industry - The FDA's transition signals three key implications for the industry: a potential restructuring of R&D timelines due to faster review processes, an increased emphasis on data quality for AI processing, and a more informed regulatory approach as regulators adopt AI tools themselves [18][19]. - Companies are encouraged to prepare structured and standardized submission materials to facilitate AI involvement in initial reviews, enhancing data consistency and quality [22].