食品药品监管局 FDA 设立神经科学新计划 NAIN：首个项目聚焦阿尔茨海默病预防
美国食品药品监管局（FDA）10月22日宣布设立新计划「神经科学推进与创新枢纽」（Neuroscience Advancement and Innovation Nexus，简称 NAIN），统筹该局在脑与神经系统疾病领域的科学、工具与监管方法，支持相关药品、生物制品与医疗器械的研发。
据 FDA 介绍，NAIN 汇集该局三个中心的专业力量：生物制品评价与研究中心（CBER）、药品评价与研究中心（CDER）与器械与放射健康中心（CDRH）；单个申报的监管审查与决定仍由相应中心作出。计划覆盖范围包括神经与精神疾病、精神健康、成瘾与疼痛等影响脑和神经系统的病症。
NAIN 的首个项目是「阿尔茨海默病预防加速器」（Alzheimer's Prevention Accelerator），目标是推进有助于延缓或预防阿尔茨海默病的医疗产品，支持联邦政府依《国家阿尔茨海默病项目法》（NAPA）制定的国家计划。FDA 表示，神经科学产品研发面临疾病生物学认识不完整、病程与表现差异大、临床获益往往需要多年才能证明等难题，新计划将就跨中心的科学问题建立常设协调机制，并与患者、照护者、产业界、学术界与联邦伙伴沟通。
FDA 代理局长 Kyle Diamantas 表示，NAIN 的设立体现 FDA 的承诺——配合本届政府推动医疗创新的努力——确保监管科学与跨中心协作跟上神经科学的快速进展；通过 NAIN 与阿尔茨海默病预防加速器，该局正把全部专业力量投入这一最紧迫的公共卫生挑战之一。
FDA Launches Neuroscience Program NAIN, With Alzheimer's Prevention Accelerator as First Initiative
The U.S. Food and Drug Administration (FDA) announced on October 22 the launch of the Neuroscience Advancement and Innovation Nexus (NAIN), a new agency program designed to advance the science, tools, and regulatory approaches needed to support the development of medical products for conditions affecting the brain and nervous system.
According to the FDA, NAIN brings together scientific and regulatory expertise from the agency's Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH), while regulatory review and decisions on individual submissions remain with the appropriate medical product center. Its scope spans neurologic and psychiatric disorders, mental health conditions, substance use disorders, and pain.
NAIN's inaugural initiative, the Alzheimer's Prevention Accelerator, will focus on advancing medical products that help delay or prevent Alzheimer's disease, in support of the National Plan to Address Alzheimer's Disease and Related Dementias under the National Alzheimer's Project Act (NAPA). The FDA says developing neuroscience products is challenging because the biology of many conditions is incompletely understood, diseases present variably, and demonstrating meaningful clinical benefit can take many years; NAIN creates a standing forum for cross-cutting neuroscience issues and supports engagement with patients, caregivers, industry, academia, and federal partners.
"The launch of NAIN reflects FDA's commitment — in support of the Trump Administration's drive to transform health care innovation — to making sure our regulatory science and cross-center collaboration keep pace with the rapid advances happening in neuroscience," said Acting FDA Commissioner Kyle Diamantas. "Through NAIN and the Alzheimer's Prevention Accelerator, we are bringing the full breadth of FDA's expertise to bear on one of the most urgent public health challenges of our time."
来源：GSM·美国（原文链接）
图片来源：大脑皮层神经元染色显微图（资料图），Ns takes photos 摄，CC BY 4.0，经维基共享资源
