The Food and Drug Administration’s Office of Women’s Health (OWH) has updated its research roadmap to reflect key areas where new or further research is needed concerning women’s health, as well as priorities and regulatory questions for the office. Device- and diagnostic-related priorities discussed in the roadmap include biocompatibility testing for medical device materials, the identification of biomarkers related to women’s health, and using data mining and other tactics to identify post-market safety issues.
The OWH, which was established in 1994, says it has funded more than 400 research projects aimed at spurring innovation “in scientific knowledge, resulting in the discovery of novel methodologies and technologies, and
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