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Target Women’s Clinics, Keep Recruitment Open To Get More Women Into Trials, FDA Says In Guidance

This article was originally published in The Gray Sheet

Executive Summary

FDA urges device firms to use a host of strategies to beef up enrollment of women in clinical trials to support device clearances and approvals, including targeting women’s clinics for recruitment efforts and revising enrollment criteria to include more females, in a final sex-specific clinical study guidance released Aug. 22.

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