FDA (Emergency Use Authorization)

GPTKB entity

Predicate	Object
gptkbp:instanceOf	gptkb:regulatory_process
gptkbp:abbreviation	gptkb:EUA
gptkbp:administeredBy	gptkb:U.S._Food_and_Drug_Administration
gptkbp:appliesTo	biologics drugs vaccines medical products devices
gptkbp:canBeTerminated	yes
gptkbp:country	gptkb:United_States
gptkbp:criteria	gptkb:state_of_emergency no adequate approved alternatives potential benefits outweigh risks
gptkbp:duration	valid during declared emergency
gptkbp:example	gptkb:Moderna_COVID-19_vaccine gptkb:Pfizer-BioNTech_COVID-19_vaccine gptkb:Remdesivir monoclonal antibody therapies
gptkbp:firstIssueDate	2005
gptkbp:legalBasis	gptkb:Section_564_of_the_Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:notableFor	gptkb:COVID-19_pandemic gptkb:H1N1_influenza_pandemic
gptkbp:purpose	allow unapproved medical products during emergencies
gptkbp:repealedBy	yes
gptkbp:requires	Secretary of Health and Human Services declaration
gptkbp:reviewedBy	gptkb:Center_for_Biologics_Evaluation_and_Research gptkb:Center_for_Devices_and_Radiological_Health gptkb:Center_for_Drug_Evaluation_and_Research
gptkbp:bfsParent	gptkb:REGEN-COV_(casirivimab_and_imdevimab)
gptkbp:bfsLayer	7
https://www.w3.org/2000/01/rdf-schema#label	FDA (Emergency Use Authorization)