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Investigational Insights

Viewing all entries for: investigational

  • Insights
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      • investigational
Calendar 30 Day Marker Ask the Experts

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

Read More about Can a protocol get IRB approval during the 30-day IND waiting period?
Doctor talking to Nurse about an X-ray Ask the Experts

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

Read More about Can a physician submit a single humanitarian use device (HUD) submission to the IRB?
Women on computer Ask the Experts

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

Read More about What documentation needs to be submitted to the IRB for an IND exemption request?
Woman on computer doing research Ask the Experts

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

Read More about Can you provide an IRB approval before FDA’s review of the IND?
microscope Whitepapers

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

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