The Food and Drug Administration on Thursday announced the Neuroscience Advancement and Innovation Nexus, or NAIN, a program that brings together its drug, biologics and medical device centers to coordinate the science, tools and regulatory approaches for products treating conditions of the brain and nervous system, including neurologic and psychiatric disorders, substance use disorders and pain. Its first initiative, the Alzheimer’s Prevention Accelerator, will work on trial populations, stage-appropriate endpoints and the evidence needed to show that a product delays or prevents Alzheimer’s disease, in support of the National Alzheimer’s Project Act.
Acting Commissioner Kyle Diamantas said the launch reflects the agency’s commitment to making sure its regulatory science and cross-center collaboration keep pace with advances in neuroscience. The release states no deadlines or application process, so how sponsors engage with the program, and whether it changes review timelines in practice, remains to be seen.