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*NeuroNexus, Facilitating CDRH's Participation

Forecast
Federal

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The Food and Drug Administration is establishing NeuroNexus, a cross-center collaboratory integrating the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research. Scheduled for announcement in October 2027, this initiative aims to formalize a program that connects these three centers to expedite the development and review of novel therapies and diagnostics for neurological and psychiatric conditions. The program focuses on improving review efficiency and communication while sharing knowledge across the organization. Key objectives of the NeuroNexus initiative include engaging with academic, clinical, government, and industry partners to maintain current knowledge in critical project areas and supporting various congressionally mandated neuroscience programs, such as the Act for ALS and the National Alzheimer's Prevention Act. Additionally, the collaboratory will implement systems to share and track neuroscience-related activities across the participating FDA centers to ensure a coordinated approach to medical product management.

General Info

FDA establishes NeuroNexus in 2027 to expedite neurological therapy and diagnostic reviews.

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

USA

Set-Aside

NONE

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0

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Organization & Contact Information

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AgencyFood and Drug Administration → Food And Drug Administration
Contacts2 people available
OfficeN/A
Office AddressN/A
Contacts
Cdrh Acquisition Liaison
To Be Determined To Be DeterminedContracting Officer

Full Description

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NeuroNexus is a collaboratory of review groups within the Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Center for Biologics Evaluation and Research (CBER) who review medical products used in the treatment, diagnosis, or management of neurological and psychiatric diseases and conditions. FDA is intending to announce this new cross-Center initiative in October 2027.The NeuroNexus collaboratory will formalize a program to connect the 3 FDA centers with the following main objectives:Expedite the development and review of novel therapies and diagnostics intended to treat, diagnose, or manage neurological and psychiatric disorders through shared knowledge, review efficiency, and cross-center communication.Engage with other government, academic, clinical professional, patients, and industry partners to obtain up-to-date knowledge and activities on identified project areas.Support congressionally mandated neuroscience programs, such as the Act for ALS, Neurology Drug Program, National Alzheimer's Prevention Act, etc.Share and track information on neuroscience related activities within each center

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Hagerty Consulting, Inc.

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