Report levels of activity regarding women's participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across where appropriate, age, biological, and sociocultural contexts. (1)Findings from these studies will inform on participation of women in clinical trials as well as analysis for safety and efficacy in women vs. men. These determinations will subsequently address women’s treatment needs, and optimize the risk benefit ratio. Findings from funded studies will expand the knowledge base with regard to sex differences in disease prevalence and response to treatment. This will subsequently inform labeling and catalyze further research to understand sex differences and women’s health issues.1. Support studies to track the participation of women in clinical trials and collaborate with FDA Centers to understand sex differences in disease prevalence and response to treatmentOngoingCompleted4/30/2010 (and ongoing)2. Assess applications FDA Centers receive for sex based analysisOngoingOngoingOngoingsuba. Award intramural funding for Phase I and II (Study Analysis) to the Center for Drug Evaluation and Research (CDER)4/30/2010Completed4/30/2010subb. Complete Phase III (Tracking) for 2007, 2008, and 200911/30/2010Completed11/30/2010subc. Initiate Phase III (Sex-Based Analysis)2/28/2011Completed2/28/20113. Evaluate Office of Women’s Health (OWH) funded studies in various therapeutic areas (e.g., cardiovascular disease, oncology, medical devices, diagnostic tests, biologics, etc.)9/30/2010Completed11/30/2010(1) This OWH project is an ongoing effort. The milestones listed are only the most recent examples of OWH's work in this area.http://www.fda.gov/AboutFDA/Transparency/track/ucm237975.htmFDA-TRACK Health Care Reform Dashboard