ABC-FDA TAP Program Partnership

Support from two grants enables a collaboration between the American Brain Coalition (ABC) and the US Food and Drug Administration (FDA) to test a new multidirectional engagement model to embed patient and family perspectives in regulatory processes and decision-making, via the FDA Total Product Life Cycle Advisory Program (FDA-TAP). Through leveraging existing relationships and hosting gatherings, the ABC aims to align priorities and incentives, facilitate engagement, and strengthen relationships among scientific, community, and FDA stakeholders. This effort seeks to ensure that patient and family needs are meaningfully considered early at early stages in neurotechnology development, while serving an overarching goal of cultivating trust and meaningful interactions among brain health community stakeholders, FDA, and industry groups within the FDA-TAP.  

Building on the success and knowledge derived from an initial $150,000 grant, supplemental funding provided by the Dana Foundation allows ABC to deepen its partnership with the FDA and develop a more comprehensive community engagement training program. The original grant established a platform that connected numerous advocacy organizations, FDA-TAP-enrolled neural device companies, and FDA representatives. The new funding supports additional capacity to meet increased demand, as well as the creation of engagement training programs for brain health advocacy groups and neural device developers. These efforts aim to sustain ABC’s collaboration with the FDA through a model that supports long-term engagement. By embedding community perspectives into regulatory processes and promoting meaningful interaction, this initiative strengthens trust and collaboration among patient advocates, device developers, and the FDA, promoting inclusive and impactful advancements in brain health technology.  

This grant supports the Dana Frontiers objectives to 1) to develop engagement resources to cultivate and improve the quality of relationships between neuroscience practitioners, policymakers and communities of people, and 2) pilot multidirectional engagement opportunities to embed community perspectives in research, policy, and decision-making.