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Compliance In Focus


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Posted by Stephani Hulec on Wed, Mar 04, 2015

Women in Post-Approval Medical Device Studies

Should women be treated differently than men in regards to medical device trials?  According to this recent medical news statement, the FDA feels that more should be done to ensure that an adequate number of women are enrolled in post-approval studies, to analyze any potential differences caused by gender.  The Journal of Women's Health recently published an article entitled Enrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the FDA.

Topics: Women, Post Approval Studies, Medical Studies, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

“HoW” the FDA is Looking at Women and Medical Devices

Topics: Medical Devices, Women, "HoW", Cardiovascular Disease

Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.