10-14-2020, 03:50 PM
The "emergency" in this case represents the pandemic. As soon as the pandemic declaration is over, the EUAs will expire.
https://en.wikipedia.org/wiki/Emergency_...horization
The EUA carries specific language about the patient population; here's the EUA for remdisivir:
https://www.fda.gov/news-events/press-an...spitalized
We will see what the language for monoclonal antibodies says.
BC
https://en.wikipedia.org/wiki/Emergency_...horization
Quote:EUAs end once the Secretary of Heath and Human Services determines that the precipitating emergency has ended (in consultation with the issuer of the appropriate state of emergency as necessary), or once the product or unapproved use is approved through normal channels.[1]
The EUA carries specific language about the patient population; here's the EUA for remdisivir:
https://www.fda.gov/news-events/press-an...spitalized
Quote:Today, as part of its ongoing efforts to fight COVID-19, the U.S. Food and Drug Administration broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.
We will see what the language for monoclonal antibodies says.
BC