The US Food and Drug Administration (FDA) has launched the Neuroscience Advancement and Innovation Nexus (NAIN), a new programme aimed at advancing the development of medical products for conditions affecting the brain and nervous system.
The initiative aligns with the Trump Administration’s efforts to accelerate medical innovation and deliver breakthrough treatments.
NAIN’s first initiative, the Alzheimer’s Prevention Accelerator, will focus on advancing medical products that could help delay or prevent Alzheimer’s disease. Both initiatives support the National Alzheimer’s Project Act (NAPA), the federal government’s comprehensive roadmap for coordinated action on Alzheimer’s and related dementias.
“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-centre collaboration keep pace with the rapid advances happening in neuroscience,” said Acting FDA Commissioner Kyle Diamantas, JD.
“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,” he added.
NAIN will bring together scientific and regulatory experts from three FDA centres: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Devices and Radiological Health (CDRH).
This cross-centre collaboration will address scientific and regulatory questions that require coordinated consideration across drugs, biologics and medical devices.
The programme will cover a broad range of conditions affecting the brain and nervous system, including neurological and psychiatric disorders, substance use disorders and pain. It will also facilitate engagement with patients, industry, academia and other stakeholders to advance research and development.
Under the Alzheimer’s Prevention Accelerator, the FDA will explore innovative approaches to advancing clinical trials for Alzheimer’s disease prevention and early-intervention drug development.
The initiative will draw on expertise from across the agency and involve patients and caregivers, researchers, industry representatives, public-private partnerships and other government agencies.
