FDA Expanded Access Program at the University of Michigan

For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing UM-Expanded-Access-Request@med.umich.edu

The FDA Expanded Access program allows a qualified physician to access investigational drugs, biologics, and devices outside of a traditional clinical trial access mechanism for emergent/ compassionate treatment of patients under limited circumstances when meeting certain criteria. FDA regulations allow access to investigational drugs/devices for treatment purposes on a case-by-case basis.

For expanded access uses, FDA requires a special submission for drugs, biologics, or devices. IRB initial and continuing approval at convened Board, and informed consent per usual IRB requirements, are required. For Emergency Use cases, some of these requirements may be met after the fact: see “IRB oversight” heading at IRBMED Emergency Use guidance webpage.

MICHR IND / IDE Investigator Assistance Program (MIAP) assists U-M physicians seeking to use FDA Expanded Access Program in

  • understanding the regulatory process involved, and assists in
  • fulfilling reporting obligations to the FDA
  • fulfilling reporting obligations to the IRB, including the eResearch application

There is no charge to physicians for MIAP services related to Expanded Access.

ADDITIONAL RESOURCES

U-M HRPP Operations Manual Part 8.III

IRBMED Standard Operating Procedures Part 8.III

IRBMED website guidance

FDA Guidance, Information, and regulations on Expanded Access