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