MIAP was established to provide comprehensive regulatory support, guidance, and education services to faculty investigators involved in US FDA regulated clinical research at UM. MIAP's primary focus is to offer regulatory assistance to sponsor-investigators of a new drug, biologic or medical device to ensure clinical research excellence and regulatory compliance, as set forth by the UM and the FDA. The MIAP program offers regulatory assistance to Investigators planning to utilize either a drug or biological product classified by the FDA as an IND per 21 CFR 312, or an investigational medical device subject to IDE regulations, per 21 CFR 812.
