The FDA plays an important role in translating NIH-sponsored research into marketed therapies for patients.  This role is especially critical in the area of cancer where patients wait anxiously for life saving treatments to come to market.  Over the past several years, the FDA, industry, and orgnaizations have worked to address the pressing issues facing cancer drug development.

Critical Path Initiative:  The Critical Path Initiative (CPI) was launched in 2004 to address the difficulty and unpredictability surrounding medical product development.  CPI is the FDA’s national strategy to “drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured.”  The cornerstone to CPI is stakeholder engagement and collaboration in and effort to gather the best information, technologies, and tools to streamline product innovation and translate research into treatments.

Reagan Udall Foundation:  Established by Congress in 2007, the mission of the Reagan-Udall Foundation is to “identify and address unmet scientific needs in the development, manufacture and evaluation of the safety and effectiveness of FDA-regulated products, including post-market evaluation.”  Although the function of the Reagan-Udall Foundation is to support the FDA’s scientific priorities, it operates as a nonprofit organization independent of the agency and is prohibited from advising the FDA on policy matters.