The FDA recently announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. “This collaboration with the PATH-MVI supports the overall mission of the FDA and specifically the Agency’s work under our Critical Path Initiative,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. “We are actively seeking ways to help organizations such as PATH develop safe and effective products that can benefit the public health both in the United States and globally.” PATH is an international, nonprofit organization that creates sustainable, culturally relevant solutions to improve global health and well-being. PATH-MVI supports the development of malaria vaccines and is expected to spearhead the efforts to ensure their availability and accessibility in the developing world once a safe and effective vaccine becomes available. The PATH-MVI collaborative project is expected to span about three years and is being conducted under the Cooperative Research and Development Agreement (CRADA) program, which allows federal laboratories and businesses to form partnerships that help expedite research activities. Recent scientific advances suggest that vaccines based on live, weakened (attenuated) malaria parasites may be possible in the future but assessing safety and effectiveness in the early stages of product development is challenging. Under this CRADA, PATH-MVI provides the FDA with about $1.5 million to develop tests for evaluating malaria vaccines early in their development. To date, there are no approved vaccines to prevent malaria but several vaccines are in development. This CRADA will help develop laboratory tests to assess whether a vaccine candidate is safe enough to begin Phase I clinical trials. Each year 350-500 million cases of malaria occur worldwide, killing an estimated one million people, most of them young children in sub-Saharan Africa. Travel between the United States and the affected areas, as well as men and women in the U.S. military who are stationed in regions at high risk for malaria, can bring the disease into the United States. The Center’s Global Vaccine Initiative fosters the development, evaluation and availability of vaccines needed to protect against major global infectious diseases and is part of the Center’s commitment to work with others, including the World Health Organization, in advancing global public health. The Critical Path Initiative is the FDA’s effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated and manufactured.