Demonstration of the Pre–Emergency Use Authorization Path Using 3 Minor Groove Binder–Hydrolysis Probe Assays to Detect Escherichia coli O104:H4
Abstract
The Department of Defense (DoD) and the Food and Drug Administration (FDA) have collaboratively worked on a pre–Emergency Use Authorization (pre-EUA) process for in vitro diagnostic (IVD) devices, using FDA's regulatory flexibilities under the EUA authorities. The pre-EUA process enables FDA review of data in anticipation of a request for an EUA, advancing US government public health emergency preparedness efforts.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Nov 01, 2015
- Source ID
- 10.1373/clinchem.2015.242750
Entities
People
- Ashley M Zovanyi
- David A. Kulesh
- David A. Norwood
- J Peyton Hobson
- James G. Jaissle
- Laurie J. Hartman
- Megan L Heinrich
- Michael F. Ingram
- Philip D. Craw
- Timothy D Minogue
Organizations
- Defense Threat Reduction Agency
- Food and Drug Administration
- United States Army Medical Research Institute of Infectious Diseases