|
gptkbp:instanceOf
|
regulatory authorization
|
|
gptkbp:appliesTo
|
drugs
vaccines
medical products
diagnostic devices
|
|
gptkbp:awardedBy
|
gptkb:U.S._Food_and_Drug_Administration
|
|
gptkbp:country
|
gptkb:United_States
|
|
gptkbp:criteria
|
state of emergency
no adequate approved alternatives
potential benefits outweigh risks
|
|
gptkbp:distinctFrom
|
FDA approval
|
|
gptkbp:duration
|
valid only during declared emergency
|
|
gptkbp:fullName
|
gptkb:Food_and_Drug_Administration_Emergency_Use_Authorization
|
|
https://www.w3.org/2000/01/rdf-schema#label
|
FDA EUA
|
|
gptkbp:introducedIn
|
2005
|
|
gptkbp:legalBasis
|
gptkb:Section_564_of_the_Federal_Food,_Drug,_and_Cosmetic_Act
|
|
gptkbp:notFullApproval
|
true
|
|
gptkbp:purpose
|
allow unapproved medical products during emergencies
|
|
gptkbp:repealedBy
|
gptkb:U.S._Food_and_Drug_Administration
|
|
gptkbp:usedDuring
|
gptkb:COVID-19_pandemic
gptkb:H1N1_influenza_pandemic
|
|
gptkbp:usedFor
|
gptkb:COVID-19_treatments
gptkb:COVID-19_vaccines
COVID-19 diagnostic tests
|
|
gptkbp:bfsParent
|
gptkb:BinaxNOW
|
|
gptkbp:bfsLayer
|
7
|