Activities of the Pharmaceutical Industry Relative to the Fda Gender Guideline *

This paper covers the issues surrounding the use of women of childbearing potential in clinical trials. It provides an overview of the proposed Food and Drug Administration (FDA) Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, then provides the perspectives of the pharmaceutical industry and the FDA on the guideline. All parties participating in research are actively seeking out new ways to abide by the guideline and protect the rights of the women who participate in clinical trials. Continued communication between FDA and industry is imperative so that the goals of the guideline can be realized.