What is this service?
Expanded access is a program through the FDA that allows patients with no clinical options to request investigational products for the diagnosis, monitoring, or treatment of a serious disease or injury. To receive permission to use an investigational drug or device, the clinician must show that:
- There is no comparable or satisfactory alternative for the patient,
- The risk of the investigational product is not greater than the risk from the condition,
- The patient is not eligible for a clinical trial, and
- The manufacturer of the product provides permission.
The MICHR IND/IDE Investigator Assistance Program (MIAP) team provides assistance for physicians throughout the process of requesting expanded access. This includes communication with the drug or device manufacturer, preparation and submission of the application to the FDA, preparation and submission to the IRB, and maintenance of the applications. MICHR provides central management of these applications on behalf of the physician and will coordinate the appropriate services in Research Pharmacy, the Office of Research Sponsored Programs, and elsewhere as needed.
Who can use this service?
A licensed physician must submit the request, but any clinician or member of a clinical team may contact MICHR if they have a patient who may qualify.
When should I contact MICHR about this service?
You should contact MICHR as soon as it is decided that the patient may benefit from an investigational product.
How much does this service cost?
This service is provided free of charge to clinicians through funds provided by Michigan Medicine. The cost pricing/recharge rates for other MICHR services are available here.