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IND/IDE Application Preparation & Submission

Support and expertise to prepare and submit investigational new drug (IND) and investigational device exemption (IDE) applications to the FDA

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Who?

Any U-M researcher who requires FDA 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.

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When?

Contact MICHR as soon as you are interested in this offering.

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How much?

Fee-based at $81/hour.

What is this offering?

The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support and expertise to prepare and submit Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications to the FDA, which may be required for the use of investigational drugs and devices in clinical research. Please reference the Medical School policy regarding MIAP support for faculty Sponsor Investigators.

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.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.

Translational Science Categories:

Designing a Study /

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