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