Guidance

FDA Expanded Access Program at the University of Michigan

IRBMED
May 7, 2018 10:00 am

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.

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: May 24, 2018 9:00 AM