FDA Emergency Use Authorization

GPTKB entity

Predicate	Object
gptkbp:instanceOf	regulatory process
gptkbp:abbreviation	gptkb:EUA
gptkbp:administeredBy	gptkb:U.S._Food_and_Drug_Administration
gptkbp:application	medical product manufacturers
gptkbp:appliesTo	biologics drugs medical devices vaccines diagnostics
gptkbp:canBeTerminatedBy	gptkb:Secretary_of_Health_and_Human_Services gptkb:FDA
gptkbp:criteria	no adequate, approved, and available alternatives risk-benefit analysis evidence of effectiveness serious or life-threatening diseases or conditions
gptkbp:duration	valid until emergency declaration ends or revoked
gptkbp:firstIssueDate	2005
https://www.w3.org/2000/01/rdf-schema#label	FDA Emergency Use Authorization
gptkbp:legalBasis	gptkb:Section_564_of_the_Federal_Food,_Drug,_and_Cosmetic_Act
gptkbp:notableFor	gptkb:COVID-19_vaccines gptkb:H1N1_influenza_pandemic COVID-19 diagnostic tests
gptkbp:purpose	allow use of unapproved medical products in emergencies
gptkbp:repealedBy	gptkb:FDA
gptkbp:requires	public health emergency declaration
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:website	https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
gptkbp:bfsParent	gptkb:Sofia_SARS_Antigen_FIA gptkb:BinaxNOW_COVID-19_Ag_Card gptkb:BinaxNOW_COVID-19_Antigen_Self_Test gptkb:Clear_Dx gptkb:FDA_authorization gptkb:T2SARS-CoV-2_Panel
gptkbp:bfsLayer	8