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Compliance In Focus


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Posted by Jaime Wynbrandt on Fri, Feb 19, 2016

Post-Approval Studies: Similarities and Differences from Pivotal Studies

FDA has the authority to require Sponsors to conduct a Post-Approval Study (PAS) at the time of approval of a Pre-Market Approval (PMA) to assess the continued safety and effectiveness of an approved device. Failure to complete a Post-Approval Study could result in the FDA taking away the PMA. How are Post-Approval Studies similar and different to Pivotal Studies?

Topics: Post Approval Studies, FDA, Pre-Market Approval, IDE Studies

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

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.