Emergency Use Authorization

GPTKB entity

Predicate	Object
gptkbp:instanceOf	gptkb:regulatory_process
gptkbp:abbreviation	gptkb:EUA
gptkbp:appliesTo	gptkb:United_States drugs vaccines medical products diagnostic devices
gptkbp:awardedBy	gptkb:U.S._Food_and_Drug_Administration
gptkbp:criteria	gptkb:state_of_emergency no adequate approved alternatives potential benefits outweigh risks
gptkbp:firstIssueDate	2005
gptkbp:legalBasis	gptkb:Section_564_of_the_Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:notableExample	gptkb:COVID-19_vaccines gptkb:remdesivir monoclonal antibody treatments
gptkbp:notFullApproval	true
gptkbp:purpose	allow unapproved medical products during emergencies
gptkbp:relatedTo	gptkb:compassionate_use expanded access conditional marketing authorization
gptkbp:reviewedBy	gptkb:FDA_Center_for_Biologics_Evaluation_and_Research gptkb:FDA_Center_for_Devices_and_Radiological_Health gptkb:FDA_Center_for_Drug_Evaluation_and_Research
gptkbp:revokedIf	emergency ends product fails to meet criteria
gptkbp:bfsParent	gptkb:Section_564_of_the_Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:bfsLayer	6
https://www.w3.org/2000/01/rdf-schema#label	Emergency Use Authorization