PubMed

医療機器治療の安全性と有効性を向上させるための政策

PMID: 27028582 · 2016-03-30

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学術誌Journal of women's health (2002)

年2016-03-30

PMID27028582

抄録

When not enough women are included in many clinical trials, an information gap on medical device safety and effectiveness exists, which can make it difficult to detect sex-specific results. In this article we discuss potential reasons for the underrepresentation of women and the regulatory research conducted by the U.S. Food and Drug Administration (FDA) used in supporting regulatory decisions. We demonstrate that important differences in cardiovascular device performance between women and men e

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