Investigational Insights

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Can a protocol get IRB approval during the 30-day IND waiting period?

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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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microscope

Under the Microscope: Biomarker and Diagnostic Tests as FDA-Regulated Devices

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