IND/IDE Lifecycle Maintenance

Support for all submissions to the FDA for sponsor-investigated studies conducted under an investigational new device (IND) or investigational device exemption (IDE).

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Any U-M researcher who holds the sponsor responsibilities of an IND or IDE.


Contact MICHR as soon as an IND or IDE is granted or required.

How much?

Fee-based at $81/hour.

What is this offering?

The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support for all submissions that may be required under an active IND or IDE, which might include:

  • Annual reports
  • Amendments
  • Safety and Adverse Event reports
  • Request for Withdrawal or Inactivation
  • All FDA forms and correspondence.

How this advances translational science

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

Translational Science Categories: