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FDA Critical Path Initiative addresses differences between women's and men's health outcomes

Published on December 20, 2007 at 12:51 AM · No Comments

Advanced medical technology and analysis methods now being promoted through the Food and Drug Administration's Critical Path Initiative to facilitate the development of drugs, biologics and devices can help address differences between women and men in the detection and treatment of disease, according to a paper published in the Winter 2007 issue of Drug Discovery Today: Technologies.

“Biological sex differences affect most disease areas,” said Sherry Marts, Ph.D., vice president of scientific affairs at the Society for Women's Health Research and an author of the paper. “And the scientific community increasingly recognizes the importance of appropriately studying women and including them in all phases of research so that we can develop the right tools for treating them.

“However, the cost of thoroughly studying subpopulations can drive up research costs and lengthen the time it takes to develop new treatments. The good news is that cutting edge research and evaluation tools such as biomarkers, pharmacogenetics and bioinformatics can improve and accelerate medical research and help address the tough questions about population differences we now have.”

The paper, authored by Marts and Ameeta Parekh, Ph.D., Wendy Sanhai, Ph.D., and Kathleen Uhl, of the FDA, outlines promising technologies that speed the development of new treatments.

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