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FDA’s Roadmap to Combat the Gender Gap in Clinical Research

Amidst growing concern that the needs of women are being overlooked by academics and pharmaceutical companies, the FDA’s Office of Women’s Health (OWH) has released a roadmap to help
guide researchers as they seek to close this gender gap. Dr Mari Heghinian and Alexandre Mouravskiy at Biorasi explain that at the heart of the problem is a simple fact. Most pharmaceutical research overwhelmingly tends to focus on men. This manifests not only in fewer breakthrough therapies for women’s health issues, but also in a lack of full understanding of the safety and efficacy of generalpurpose medications in female populations.