What is this service?
The MICHR IND/IDE Investigator Assistance Program (MIAP) provides consultation on research involving investigational agents (drugs, devices, and biologics) that includes:
· Determination of 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.
Who can use this service?
This service may be used by any U-M investigator who is using (or intends to use) an investigational agent in human research participants, at any stage in research, from idea to trial.
At what stage in my research should I contact MICHR about this service?
You may contact MIAP as soon as you have an idea that may, at some point, involve a clinical trial utilizing an FDA-regulated drug or a device. The sooner you contact MIAP about your idea, the better they can help you through the regulatory pathway.
How much does this service cost?
Initial consultations are at no cost.
The start-up fee for an IND or IDE submission is $1,000, which may be waived in special circumstances.