The Food and Drug Administration (FDA) released an initial list of priority research projects that could advance innovation in medical products. The announcement of the Critical Path Opportunities List signals the next major step in FDA’s Critical Path Initiative aimed at modernizing medical product development, so new medical discoveries are brought to patients faster and at a lower cost.
Critical Path is the FDA’s initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. Its primary purpose is to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments by creating new tools to find answers about how the safety and effectiveness of new medical products can be demonstrated in faster timeframes with more certainty, at lower costs, and with better information.
The Opportunities List outlines an initial 76 projects to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are currently developed into therapies.
The Critical Path Opportunities Report is organized into six broad topic areas: development of biomarkers; clinical trial designs, bioinformatics, manufacturing, public health needs and pediatrics. FDA’s outreach efforts uncovered a consensus that the two most important areas for improving medical product development are biomarker development and streamlining clinical trials.
Over the next few weeks, the FDA will identify several priority Critical Path research opportunities. Some of the projects in the list could be undertaken by one organization; some will require collaborations coordinated and supported by the FDA.
Information on the Critical Path Initiative, is available here.
