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Statements (17)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:regulatory_process
|
| gptkbp:abbreviation |
gptkb:EUA
|
| gptkbp:appliesTo |
biologics
drugs medical devices |
| gptkbp:awardedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:can_be_revoked_by |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:criteria |
gptkb:state_of_emergency
no adequate, approved, and available alternatives |
| gptkbp:duration |
temporary
|
| gptkbp:introducedIn |
2005
|
| gptkbp:legalBasis |
gptkb:Section_564_of_the_Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:purpose |
allow use of unapproved medical products in emergencies
|
| gptkbp:used_in |
gptkb:COVID-19_pandemic
|
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
4
|
| https://www.w3.org/2000/01/rdf-schema#label |
emergency use authorization
|