Gene Therapy Insights

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guidance documentation

Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”

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[Video] Institutional Biosafety Committee Review: Strategies to Secure Rapid IBC Approval for Human Gene Transfer Trials

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Four Key Elements You Need to Know About the Role of IBCs in Gene Therapy Trials

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[Webinar] IRB and IBC Required Approvals in Gene Therapy: Addressing Challenges in a Growing Market

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As a sponsor, does my HGT clinical trial require IBC approval at all sites?

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Does Human Gene Transfer research at my site require IBC approval?

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How should we handle financial conflicts of interest in FDA-regulated clinical trials?

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Ethical and Biosafety Oversight of Gene Transfer Clinical Research: What Sponsors and CROs Need to Know

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