Expanded Access to Investigational Products

Support for navigating the FDA’s Expanded Access Program to obtain investigational drugs, biologics or devices for patients with no other clinical options

What is this offering?

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 single patient 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 connects the physician with the appropriate services in Research Pharmacy, the Office of Research Sponsored Programs, and elsewhere as needed.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.

MICHR Publications

• National landscape assessment of academic medical center support for expanded access to investigational products | Journal of Clinical and Translational Science | Cambridge University Press

• Adapting an Expanded Access program to enable investigational treatments for COVID-19 | Journal of Clinical and Translational Science | PubMed Central