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[October 2024] The Regulatory Submissions Issue: Best Practices for Preparing IND and PMA Applications + Warning Letter Breakdown

This month we're focusing on high-stakes regulatory submissions and quality system compliance, with practical guidance you can implement today to avoid common pitfalls and strengthen your submissions.

Welcome to Insider issue #30.

And a very warm welcome to the 471 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.

The FDA Group's Insider Newsletter is a reader-supported publication. To receive new posts and support our work, consider becoming a paid subscriber.

In this month’s pharma section,

In our pharma section, Talita Ferreira provides a comprehensive guide to preparing Investigational New Drug (IND) applications, sharing ten essential best practices drawn from real-world experience that can help streamline your submission process and improve your chances of success.

Our device feature sees Jon Wacks breaking down the critical elements of preparing a Premarket Approval (PMA) application. Drawing on decades of experience, he offers detailed insights into everything from Quality Management System requirements to clinical study design, providing a practical roadmap for navigating this complex submission process.

Finally, we analyze a July 2024 warning letter issued to Globus Medical regarding their Excelsius GPS surgical robot. The letter reveals significant quality system violations, including CAPA deficiencies and MDR reporting failures, offering crucial lessons for medical device manufacturers about maintaining robust quality systems for complex surgical devices.

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The FDA Group's Insider Newsletter
The FDA Group's Insider Newsletter
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The FDA Group