FDA Looks For More Women In Medtech Trials

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Based on the results of a newly unveiled study, the FDA plans to implement new processes to ensure that women make up an appropriate portion of medical device post-approval studies. Nearly half of the premarket approvals and humanitarian device exemptions handed out since 1991 have included post-approval approval requirements, and sex-based data is available for more than 90% of them, according to the study authors. The reports show that women frequently make up less than half of the patients population in cardiovascular, orthopedic, and renal/urologic studies.

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