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The Food and Drug Administration’s (FDA’s) Office of Women’s Health (OWH) today announced it has awarded contracts to seven academic institutions to conduct clinical research on women’s health issues. The research conducted under these contracts is designed to provide FDA’s OWH with the data needed to help FDA make decisions on issues involving women’s health.
In June 2003, FDA’s OWH solicited proposals from women’s health research networks capable of conducting clinical studies. FDA reviewed the proposals it received and awarded contracts to Boston University, Indiana University, Tulane University, University of Illinois at Chicago, University of Wisconsin, University of Arizona, and University of Washington. These institutions will conduct research studies to address to specific questions in women’s health over the next five years.
"The research conducted at these leading institutions will provide valuable insight into how FDA can advance its current regulatory approaches to improve women’s health," said FDA Commissioner Mark B. McClellan, M.D., Ph.D.
For example, the FDA’s contract with the University of Arizona will fund research to help determine if pregnancy changes the activity of the antidepressant medication sertraline. A second study, at Boston University, will look at factors influencing blood glucose monitoring for diabetes via fingertip vs. drawing blood samples from other locations on the body in both women and men.
"These contracts demonstrate how FDA is leveraging its resources by forming partnerships with academic institutions to identify and address important women’s health issues," said Susan F. Wood, Ph.D., Assistant Commissioner for Women’s Health.
Under the terms of the contracts, over the next five years, the FDA will be able to award competitive, women's health related projects to one or more of the seven institutions.
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