Date of Award
Master of Public Health (MPH)
Dr. Samer Koutoubi
The purpose of this study is to present an argument for the expansion of the Emergency Use Authorization beyond the current scope of threats that cover chemical, biological, radiological, or nuclear agents and to include instruments of war or terrorism (explosive devices or agents), or hazards which cause or threaten to cause massive physical trauma. A literature search using PubMed, the Defense Technical Information Center, and Google Scholar identified 26 articles from January 1982 to December 2014 that examined the effects of blast as an instrument of war on combat casualty care. An assessment was made of each article that included a medical product in either pre-clinical or clinical trial status, a medical product that the Food and Drug Administration approved for another indication other than a particular trauma indication, or a product approved by a foreign regulatory entity. The results show a major gap in the Emergency Use Authorization that requires expansion to allow the Food and Drug Administration to grant authorization for an unapproved medical product (or unapproved use of an approved product) that is the best available medical countermeasure for trauma care.
Rauch, Terry M., "Current Limitations of the Emergency Use Authorization: The Need to Strengthen All-Hazards Preparedness for Medical Products to Support US Military Forces" (2015). Master's Capstone Theses. 37.
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