Emergency Use Authorization (EUA)
GPTKB entity
Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory mechanism
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
drugs
vaccines medical products diagnostic devices |
| gptkbp:canBeTerminated |
true
|
| gptkbp:country |
gptkb:United_States
|
| gptkbp:criteria |
state of emergency
no adequate, approved, and available alternatives potential benefits outweigh potential risks |
| https://www.w3.org/2000/01/rdf-schema#label |
Emergency Use Authorization (EUA)
|
| gptkbp:introducedIn |
2004
|
| gptkbp:legalBasis |
gptkb:Section_564_of_the_Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:purpose |
allow use of unapproved medical products in emergencies
|
| gptkbp:repealedBy |
gptkb:U.S._Food_and_Drug_Administration
true |
| gptkbp:usedDuring |
gptkb:COVID-19_pandemic
|
| gptkbp:usedFor |
gptkb:COVID-19_treatments
gptkb:COVID-19_vaccines COVID-19 diagnostic tests |
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|