IND/IDE Application Preparation & Submission

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What is this service?

The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support and expertise to prepare and submit Investigational New Drug and Investigational Device Exemption applications to the FDA, required for the use of investigational drugs and devices in clinical research.

In addition to standard applications, MIAP can advise and assist U-M investigators who may require alternate regulatory approval, including exemption, risk determination, humanitarian use device, and orphan drug applications.

Who can use this service?

This service may be used by any U-M investigator who requires approval for use of an investigational agent in human research participants. Investigators must be affiliated with U-M and intend to hold the sponsor responsibilities of the IND or IDE.

MIAP does not provide this support for INDs or IDEs held by industry or outside the university.

When should I contact MICHR about this service?

You should contact MIAP as soon as you start planning research in human participants with an investigational drug, device, or biologic.

How much does this service cost?

MICHR/MIAP charges a flat fee of $75 per hour for time spent on IND/IDE application preparation and submission activities.  Please contact MICHR MIAP for assistance with budgetary planning.

 

IND/IDE Application Preparation & Submission

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