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Key Takeaways From FDA’s New Draft Guidance, “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial”

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Can a physician submit a single humanitarian use device (HUD) submission to the IRB?

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What documentation needs to be submitted to the IRB for an IND exemption request?

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Can you provide an IRB approval before FDA’s review of the IND?

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