Behind the Insights: Ep 06 FDA Draft Guidance on Post-Approval Data for Cell & Gene Therapies
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Behind the Insights: Ep 06 FDA Draft Guidance on Post-Approval Data for Cell & Gene Therapies
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In this episode of Behind the Insights, Rich Gliklich, MD, Founder and CEO and Michelle Leavy, MPH, Senior Director, Registries at OM1 unpack the FDA's new draft guidance on Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products. They'll discuss practical considerations sponsors need to know and provide expert insights on compliant, cost-effective postapproval data strategies.
0:00 Intro
0:33 What is the new FDA draft guidance about and why is it important?
2:45 Main limitations of traditional real-world data sources?
4:09 How do registries fill gaps?
6:13 Decentralized data collection in practice
8:22 What do sponsors need to keep in mind?
9:22 Final thoughts
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