Support for all submissions to the FDA for sponsor-investigated studies conducted under an investigational new device (IND) or investigational device exemption (IDE)
Offering Type: Offerings
Expert consultation for researchers on FDA regulatory requirements and compliance for studies involving investigational drugs, devices, and biologics
Training required for sponsor investigators conducting studies under an investigational new drug (IND) or investigational device exemption (IDE) to ensure compliance with investigational research regulations
Connect with epidemiologists, biostatisticians, data analysts, and data scientists across U-M to enhance your health research outcomes
Engage with data analysis experts to ensure rigor in your clinical and translational research