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."
Source: GSM · USA (original Chinese edition)
Photo: 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
