THIS WAS A GREAT LINK PLUTO! JUST ONE MAJOR HIG
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Posted On: 03/17/2020 12:55:39 AM
THIS WAS A GREAT LINK PLUTO!
JUST ONE MAJOR HIGHLIGHT:
The Centers for Disease Control and Prevention (CDC) laboratories have supported the COVID-19 response, including development of a diagnostic assay that was issued an Emergency Use Authorization (EUA) on February 4, 2020.2 Since authorizing CDC’s EUA, FDA has been actively working with other SARS-CoV-2 diagnostic test developers to help accelerate development programs and respond to requests for in vitro diagnostic EUAs...
HOWEVER, THE SEVERITY AND SCOPE OF THE CURRENT COVID-19 SITUATION AROUND THE GLOBE NECESSITATES GREATER TESTING CAPACITY FOR THE VIRUS THAN IS CURRENTLY AVAILABLE. (footnote 3)
The EUA authorities allow FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures initiatives (MCMs) needed during certain public health emergencies. Under section 564 of the FD&C Act,
THE FDA COMMISSIONER MAY AUTHORIZE THE USE OF UNAPPROVED MEDICAL PRODUCTS, OR UNAPPROVED USES OF APPROVED MEDICAL PRODUCTS, IN CERTAIN EMERGENCY CIRCUMSTANCES, AFTER
...the HHS Secretary has made a declaration of emergency or threat justifying authorization of emergency use, to diagnose, treat, or prevent serious or life- threatening disease or conditions caused by CBRN threat agents when certain criteria are met.
GLTA! Except the LOSERS!
JUST ONE MAJOR HIGHLIGHT:
The Centers for Disease Control and Prevention (CDC) laboratories have supported the COVID-19 response, including development of a diagnostic assay that was issued an Emergency Use Authorization (EUA) on February 4, 2020.2 Since authorizing CDC’s EUA, FDA has been actively working with other SARS-CoV-2 diagnostic test developers to help accelerate development programs and respond to requests for in vitro diagnostic EUAs...
HOWEVER, THE SEVERITY AND SCOPE OF THE CURRENT COVID-19 SITUATION AROUND THE GLOBE NECESSITATES GREATER TESTING CAPACITY FOR THE VIRUS THAN IS CURRENTLY AVAILABLE. (footnote 3)
The EUA authorities allow FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures initiatives (MCMs) needed during certain public health emergencies. Under section 564 of the FD&C Act,
THE FDA COMMISSIONER MAY AUTHORIZE THE USE OF UNAPPROVED MEDICAL PRODUCTS, OR UNAPPROVED USES OF APPROVED MEDICAL PRODUCTS, IN CERTAIN EMERGENCY CIRCUMSTANCES, AFTER
...the HHS Secretary has made a declaration of emergency or threat justifying authorization of emergency use, to diagnose, treat, or prevent serious or life- threatening disease or conditions caused by CBRN threat agents when certain criteria are met.
GLTA! Except the LOSERS!
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