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Patient Engagement with the FDA

Neuroscience is a top federal funding target across a national infrastructure dedicated to understanding the brain and treating brain conditions. Despite unprecedented progress in basic neuroscience, neurological and psychiatric diseases continue to be stigmatized and have relatively limited treatment options compared with other common conditions. ABC has worked for years to address the unmet need for treatments and cures for brain conditions through building a coalition of stakeholders. Additionally, through advocacy and education, we seek to improve access and delivery of evidence-based care in all corners of the United States, so every citizen has the opportunity for the best outcome possible.

 

To achieve these goals, it is essential to improve engagement of, and input from people with  lived experience  into legislative and regulatory neuroscience processes, to speed the delivery of safe and effective treatments for brain conditions. Recent  Dana Foundation-Research!America  survey findings underline needs for a greater voice from people living with brain conditions to better define brain health research priorities and overcome obstacles to brain health research participation.

 

Influencing the regulatory process, ABC is working with the brain community and the Food and Drug Administration (FDA) to create a bi-lateral relationship ensuring the regulatory process for delivering safe and effective treatments to individuals with brain conditions includes input and feedback from people with lived experience.

FDA Total Product Life-Cycle Advisory Program (TAP) Pilot

Learn how and why ABCI2 was established, view the ABCI2 Process Summary, and review a number of outside resources articulating the problem.

Collaborate with the ABC in ensuring a more meaningful range of stakeholders, and the lived experiences of patients and their families, are included in the important conversations and decision-making processes of programming at the FDA.

Learn how your organization can create connections and leverage resources, help patients, and gain insights through innovative collaborations with industry.  

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