Emergency Use Authorization

URI: https://gptkb.org/entity/Emergency_Use_Authorization
GPTKB entity
Statements (29)
Predicate Object
gptkbp:instanceOf 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 state of emergency
no adequate approved alternatives
potential benefits outweigh risks
gptkbp:firstIssueDate 2005
https://www.w3.org/2000/01/rdf-schema#label Emergency Use Authorization
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