Reagan-Udall Foundation for the FDA: Our Work
In 2007, Congress created the Reagan-Udall Foundation for the FDA in response to the FDA’s own “FDA Science and Mission at Risk” report of the Subcommittee on Science and Technology, prepared for the FDA’s Science Board. The report assessed the state of science and technology at the FDA and its ability to support current and future regulatory science needs. The Subcommittee noted that while demands on the FDA had increased due to ongoing scientific innovation, resources had not kept up with the demands and exceeded the FDA’s regulatory scientific capacity. The Subcommittee identified critical needs in the areas of strengthening science capability, capacity and organization, as well as improving information sciences and technology.
The Reagan-Udall Foundation (Foundation) has been asked to undertake a number of important projects to improve the science, analytic evidence, and scientific capacity for supporting the mission of the FDA. The Foundation Board maintains overall responsibility for all of the Foundation’s activities. Foundation activities will include Core Operations, plus three main work streams, outlined in the organizational structure diagram. These work streams correspond to the needs outlined in the FDA Science and Mission at Risk Report.
Descriptions of Work Streams
This work stream houses programs and projects that aim to improve information sciences and technology. The Reagan-Udall Foundation plays an active role in facilitating and fostering public-private collaborations to work towards the development of tools and methods which the FDA can then use to better evaluate the safety and effectiveness of the products it regulates. [more details]
This work stream houses projects that aim to improve regulatory science processes. The Reagan-Udall Foundation plays an active role in facilitating and fostering public-private collaborations to work towards innovative solutions to regulatory science challenges through the development of new tools and novel approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. [more details]
This work stream aims to address the critical need for strengthening science capability and capacity, both within the FDA as well as externally. This program area will house the planned Reagan-Udall Foundation Fellowships pilot programs. [more details]