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FDA aims to boost inclusion of women in studies
Modern Healthcare

The Food and Drug Administration issued draft guidance that addresses how device manufacturers can design and conduct clinical studies that encourage the enrollment of women in order to ensure appropriate representation of men and women. Differences in genetics, hormones, body size, diet and social issues may affect the safety and efficacy of devices used for men and women, the FDA said in a news release announcing the guidance. According to the Dec. 16 draft guidance, women have been underrepresented or excluded from clinical studies.

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