IND/IDE FDA Pre-submission Meetings

Support and expertise to prepare and submit investigational new drug (IND) and investigational device exemption (IDE) pre-submission meeting requests 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.

When?

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

How much?

Variable depending on the complexity of the submission.

What is this offering?

The MICHR IND/IDE Investigator Assitance Program (MIAP) provides support and expertise to prepare and submit drug and device pre-submission meeting requests to the FDA regarding product development questions, including required preclinical testing and information required for IND/IDE submissions.

How this advances translational science

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

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