IND/IDE needs assessment

Guidance in assessing if you need an investigational new drug (IND) or investigational device exemption (IDE) for your study

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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.


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

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What is this offering?

The MICHR IND/IDE Investigator Assitance Program (MIAP) provides help assessing if you will need an IND or IDE for your study, advice on filling out sections 15 and 16 of your eResearch application, completing an IND or IDE decision worksheet, and determining if a submission to the FDA is needed.

How this advances translational science

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

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