Welcome to Insider issue #28
And a very warm welcome to the 612 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.
This month’s pharma feature examines two new draft guidances from the FDA covering BIMO inspections. These guidances aim to streamline the data required for biologic or new drug submission applications and aid in the review and inspection process. We discuss the key changes and provide recommendations for sites to prepare for potential inspections.
In our device/medtech feature, we unpack the FDA's new white paper on artificial intelligence in medical products. The paper outlines how CBER, CDER, CDRH, and OCP are collaborating to safeguard public health while fostering responsible AI innovation. We highlight five key takeaways and discuss their implications for the industry.
Lastly, our breakdown examines a Form 483 issued to Jiangsu Hengrui Pharmaceuticals, a Chinese drugmaker, for significant violations at its manufacturing facility. We distill the major deficiencies cited and provide actionable lessons for quality teams to enhance compliance and prevent similar issues.
A big thanks to this month’s expert contributors, Judson Russell, Michel E. Moravia, and Kittu Rao.
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