IND/IDE Consultation
Expert consultation for researchers on FDA regulatory requirements and compliance for studies involving investigational drugs, devices, and biologics
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 $90/hour.
What is this offering?
This offering, along with others from the Michigan IND/IDE Investigator Assistance Program (MIAP), has moved to the Office of Regulatory Affairs. Visit the new MIAP website to access this service.
How this advances translational science
Implementing operations that facilitate and support the quality and impact of research
Translational Science Categories: