Food and Drug Administration Emergency Use Authorization

GPTKB entity

Predicate	Object
gptkbp:instanceOf	regulatory process
gptkbp:abbreviation	gptkb:FDA_EUA
gptkbp:administeredBy	gptkb:U.S._Food_and_Drug_Administration
gptkbp:amendedBy	yes
gptkbp:appliesTo	drugs vaccines medical products diagnostic devices
gptkbp:compatibleWith	full FDA approval
gptkbp:country	gptkb:United_States
gptkbp:criteria	state of emergency no adequate approved alternatives known and potential benefits outweigh risks
gptkbp:firstIssueDate	2005
https://www.w3.org/2000/01/rdf-schema#label	Food and Drug Administration Emergency Use Authorization
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:relatedTo	FDA approval FDA expanded access
gptkbp:repealedBy	yes
gptkbp:requires	sufficient scientific evidence
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:revokedWhen	emergency ends or product is approved
gptkbp:bfsParent	gptkb:FDA_EUA
gptkbp:bfsLayer	8