Patient Engagement with the FDA
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
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FDA Neurology Drug Program
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American Brain Coalition

PO Box 1549 | Maple Grove, MN 55311

Ph: 763. 516. 3583

Email Us: communications@americanbraincoalition.org