FDA's Critical Path Initiative

The Critical Path Initiative (CPI) is FDA's national strategy to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured.

Launch

The Initiative was launched in March 2004, with the release of FDA's landmark report Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. The publication diagnosed the reasons for the widening gap between scientific discoveries that have unlocked the potential to prevent and cure some of today's biggest killers, such as diabetes, cancer, and Alzheimer's, and their translation into innovative medical treatments. 

Sounding the alarm on the increasing difficulty and unpredictability of medical product development, the report concluded that collective action was needed to modernize scientific and technical tools as well as harness information technology to evaluate and predict the safety, effectiveness, and manufacturability of medical products. The report called for a national effort to identify specific activities all along the critical path of medical product development and use, which, if undertaken, would help transform the critical path sciences. 

In March 2006, FDA's Commissioner announced the release of FDA’s Critical Path Opportunities List. Created with broad contribution from the public, the list described specific areas where the sciences of product development had the greatest need for improvement. 

It listed 76 tangible examples where new scientific discoveries—in fields like genomics, imaging, and informatics (the analysis of biological information using computers and statistical techniques) — could be applied during development to improve the accuracy of tests that predict the safety and efficacy of potential medical products.

Following the report's release, FDA launched a major drive to forge collaborations with all stakeholders to tackle identified issues. During 2006, 2007, and 2008, and 2009 numerous innovative projects were undertaken as part of CPI.

The Impact of 21st Century Challenges

Globalization, rapidly evolving technologies, and emerging areas of science are having a major impact on FDA-regulated medical products. CPI is leveraging the knowledge we've gained from these emerging scientific fields to enhance the tools FDA uses to evaluate drugs, biologics, and medical devices.

Evolving technologies are making it possible for us to implement cutting-edge information systems critical to supporting medical innovation and public health safety. CPI's 2008 Annual Report and The Critical Path Report on Key Achievements in 2009 highlight the work FDA and its collaborators have done to move toward a flexible, fully integrated electronic infrastructure, capable of receiving and communicating crucial product information. (FDA makes the most up-to-date labels of more than 6,000 prescription drugs available on the Internet at DailyMed!) This work is streamlining information management systems for FDA-regulated medical products, including adverse event reporting.

CPI — FDA's National Strategy for Driving Innovation

The monumental effort involved in creating the scientific tools and processes necessary to support 21st-Century medical product regulation cannot be undertaken by any one entity alone. It requires the collaboration of all stakeholders—federal agencies, patient groups, academic researchers, industry, healthcare practitioners, and others.

FDA is uniquely positioned to forge such collaborations and to identify the scientific hurdles to developing new treatments and cures for today's chronic diseases. The Critical Path reports on this Web site track the progress FDA is making in laying the regulatory infrastructure for safer, more effective treatments, and revolutionary cures for the years ahead.

"The Critical Path Initiative is taking us into the 21st century," said Dr. Margaret Hamburg, Commissioner of FDA. "It is fostering strong, sustained scientific advances that will enhance the health and well-being of all Americans."