Critical Path Initiative at the U. S. Food and Drug Administration (FDA)
The FDA is the Federal agency charged with the regulatory oversight of foods and drugs with respect to safety and efficacy. The FDA has articulated a “Critical Path Initiative” as a vision statement to improve the efficiency of product development industry-wide and to identify and prioritize (1) the most pressing development problems for new drugs and other therapeutic agents, and (2) the areas that provide the greatest opportunities for rapid improvement and public health benefits. Opportunities for partnership with the FDA under the Critical Path Initiative exist in a variety of areas of biomedical science. An example of a public-private partnership involving National Institutes of Health and the FDA is The Biomarkers Consortium.