Wednesday, November 5, 2014

FDA has issued Emergency Use Authorizations for Ebola diagnostic tests, but not for vaccines or drugs/ FDA


The following table is current as of October 27, 2014 per FDA.  Experimental drugs are being authorized on a compassionate use basis, for those already ill from Ebola.  I find no legal authority in the US for using experimental vaccines currently.
Diagnostic TestDateLetter of
Authorization (PDF)
Fact Sheet for 
Healthcare Providers (PDF)
Fact Sheet 
for Patients (PDF)
Labeling 
(PDF)
BioFire Defense LLC FilmArray Biothreat-E Test10/25/14[Authorization][Healthcare][Patients][Labeling]
BioFire Defense LLC FilmArray NGDS BT-E Assay10/25/14[Authorization][Healthcare][Patients][Labeling]
DoD EZ1 Real-time RT-PCR Assay10/10/14[Authorization][Healthcare][Patients][Labeling]
CDC Ebola Virus NP Real-time RT-PCR Assay10/10/14[Authorization][Healthcare][Patients][Labeling]
CDC Ebola Virus VP40 Real-time RT-PCR Assay10/10/14[Authorization][Healthcare][Patients][Labeling]

1 comment:

  1. 357 ppl being monitored in NYC:
    http://www.latimes.com/nation/nationnow/la-na-nn-ohio-ebola-free-monitoring-20141105-story.html

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