Welcome to Insider issue #25.
And a very warm welcome to the 734 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.
Our pharma feature delves into the FDA’s revised draft guidance on remote manufacturing assessments (RRAs), providing an updated approach to voluntary and mandatory remote regulatory assessments. Released towards the end of January, this guidance outlines how the FDA will utilize RRAs to understand biopharma manufacturers better and support approval decisions. It covers when and how RRAs will be conducted, the responses expected from companies, and the potential consequences of refusing a remote inspection. We given a detailed breakdown of the guidance, practical preparation advice, and specific compliance tools.
Our device/medtech feature highlights the FDA’s recent warning to medtech sponsors and manufacturers regarding potential data integrity issues with third-party testing laboratories. The FDA has observed an increase in unreliable data submissions, particularly from labs in China and India. This article underscores the importance of vigilance and oversight in ensuring data integrity. We provide key insights from the FDA's warning, detailed recommendations for ensuring data accuracy, and steps for setting up independent testing programs.
Lastly, our warning letter breakdown examines a recent FDA warning to an orthopedic implant maker for packaging deficiencies that could lead to faster degradation of implants. The warning letter offers critical lessons in handling CAPA, CGMP, and MDR. We thoroughly analyze the issues identified by the FDA and specific, actionable recommendations for quality teams to prevent similar compliance failures.
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