Statements (20)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:appliesTo |
biologics
drugs food additives medical devices tobacco products |
| gptkbp:awardedBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:basedOn |
safety and efficacy data
|
| gptkbp:cause |
gptkb:emergency_use_authorization
approval clearance |
| https://www.w3.org/2000/01/rdf-schema#label |
FDA authorization
|
| gptkbp:processor |
inspection of manufacturing facilities
review of clinical trial data |
| gptkbp:relatedTo |
gptkb:FDA_Emergency_Use_Authorization
FDA approval FDA clearance |
| gptkbp:requires |
legal marketing in the United States
|
| gptkbp:bfsParent |
gptkb:FDA_expanded_access_program
|
| gptkbp:bfsLayer |
7
|