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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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Who?
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.
When?
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
Translational Science Categories: