Although it was mandated by Congress in the Food and Drug Administration Amendments Act of 2007 to help support and promote FDA's regulatory science priorities, it is independent of the agency, with its own Board of Directors, staff and research agenda.
The Reagan-Udall Foundation creates public–private partnerships to advance research in regulatory science, enhance medical decision making, and promote innovation.
2) Funded by the Susan G. Komen for the Cure, the Reagan-Udall Foundation convened a Systems Toxicology Project with the ultimate goal of directly identifying common biological intermediates for toxicity in two classes of oncology drugs, then correlating them to an adverse event.
By having an independent, third party convener, like the Reagan-Udall Foundation, multiple companies can be readily involved, along with toxicologists, oncologists and other scientists from the FDA, National Institutes of Health and academia.
[5] As required by statute, two leading government scientists - the Commissioner of the FDA and the Director of the National Institutes of Health are ex officio members of the Board.