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FDA (Emergency Use Authorization)
URI:
https://gptkb.org/entity/FDA_(Emergency_Use_Authorization)
GPTKB entity
Statements (31)
Predicate
Object
gptkbp:instanceOf
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
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
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_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
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
gptkbp:bfsParent
gptkb:REGEN-COV_(casirivimab_and_imdevimab)
gptkbp:bfsLayer
7