2026年1月13日，美国食品药品监督管理局（FDA）发布了一项重大的药物安全性信息更新，要求从胰高血糖素样肽-1受体激动剂（GLP-1 RA）类药物的说明书中移除“自杀意念和行为（SI/B）风险”的警告信息。

2026 年 1 月 21 日，FDA《化妆品产品记录访问权限》指南草案正式进入《联邦公报》征求意见期，FDA 强调化妆品企业需在2个月内完成记录合规改造，拒绝提供记录或缺失英文译本将面临严厉处罚，包括产品扣留和个人刑责。

普林斯顿/东京 - 美国食品药品监督管理局 (FDA)已接受大冢制药 (Otsuka Pharmaceutical)提交的centanafadine新药申请 (NDA)优先审查，该药物是一种用于治疗儿童、青少年和成人注意力缺陷多动障碍 (ADHD)的每日一次用药。大冢制药市值达313.9亿美元，已成为制药行业的重要参与者。

Dr. Céline Gounder, an internist, epidemiologist and infectious disease specialist, is a CBS News medical contributor as well as senior fellow and editor-at-large for public health at KFF Health News.

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FDA许可的可穿戴脉搏血氧仪代表了一种特定的监管和技术认定。与普通健康设备或仅具有CE标志的设备不同，它已经通过了美国食品和药物管理局（FDA）的510 (k)上市前通知程序或De Novo分类途径。获得此许可的前提是，该设备必须在其预期用途和技术特性方面证明与合法上市的前代设备实质等同，或者为新型设备确立了安全性和有效性。其核心依据是在受控实验室条件及预期的真实使用场景（包括运动伪影和低灌注状态 ...