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Emergency Use of a Test Article

 

The University, the Office of the Human Research Protection Program (OHRPP) and the Food and Drug Administration wish to support a physician's obligation to treat a seriously ill patient with all available treatment modalities. The emergency use provision in the FDA regulations [21 CFR 56.104(c)] allows physicians restricted access to experimental treatments that would otherwise be off limits. The OHRPP guidance and set of procedures is aimed to support physicians by clarifying the strict FDA emergency use requirements and by outlining the necessary procedures to help ensure physicians are in full compliance with those requirements. For a quick summary, please see the checklists below.

 

Please make sure you are familiar with the guidance below before using the provisions in the regulations for the emergency use of a test article. This guidance also makes the distinction between "emergency use" and "compassionate use." The latter is also described in the guidance and should not be confused with "emergency use." Emergency use regulations are also not to be confused with research in an emergency setting which is described in OHRPP Guidance: Planned Research in Emergency Setting with Waiver of Consent. The checklists below will assist investigators in the emergency use of an unapproved drug or device.

 

If you have any questions about the procedures for or the situations in which to apply the emergency use of a test article, please call any one of the following OHRPP staff members:

 

Anthony Saldaña MIRB-1 Administrator

(310) 825-5351
Greg Ellis MIRB-2 Administrator

(310) 825-5406
Mark Mimnaugh MIRB-3 Administrator

(310) 825-4804

 

 

Page Last Updated: June 3, 2015