Welcome to Insider issue #31.
And a very warm welcome to the 592 new life science professionals who joined last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.
In our pharma feature, Diamond Dent-Mitchell examines the FDA's groundbreaking June 2024 draft guidance on Diversity Action Plans in clinical trials. She breaks down the upcoming requirements, which for the first time carry potential civil and criminal penalties, and provides actionable strategies for building sustainable diversity initiatives into clinical research programs.
Our medical device section features Jesse Hart's analysis of the FDA's new draft guidance on Use-Related Risk Analysis for drugs, biologics, and combination products. Drawing from his extensive experience, he provides a detailed roadmap for implementing effective URRA processes, with particular emphasis on practical integration into existing development workflows.
Finally, Kittu Rao analyzes a concerning a warning letter issued to Chinese syringe manufacturer Jiangsu Caina Medical Co. The letter reveals significant quality system violations, including inadequate CAPA procedures and faulty risk management, providing critical insights about the importance of robust quality systems and proactive risk assessment in medical device manufacturing.
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