IND/IDE Consultation

Expert consultation for researchers on FDA regulatory requirements and compliance for studies involving investigational drugs, devices, and biologics

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Any U-M researcher who may require 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.

How much?

Initial consultations are free. IND/IDE applications and maintenance are fee-based at $81/hour.

What is this offering?

The MICHR IND/IDE Investigator Assistance Program (MIAP) provides consultation on research involving investigational agents (drugs, devices, and biologics) that includes:

  • Determination of FDA regulatory pathway and need for an IND (Investigational New Drug) or exemption, IDE (Investigational Device Exemption), orphan disease designation, or humanitarian use device (HUD).
  • Protocol and informed consent review and assistance.
  • Assistance with FDA meeting requests, preparation, and support.
  • Expertise and guidance on navigating investigational agent regulation and compliance.

How this advances translational science

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

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