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Statements (19)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
medical treatment policy
|
| gptkbp:alsoKnownAs |
expanded access
|
| gptkbp:appliesTo |
medical devices
investigational drugs patients with serious or life-threatening conditions |
| gptkbp:category |
healthcare regulation
|
| https://www.w3.org/2000/01/rdf-schema#label |
compassionate use
|
| gptkbp:purpose |
provide access to unapproved therapies
|
| gptkbp:regulates |
gptkb:European_Medicines_Agency
gptkb:U.S._Food_and_Drug_Administration |
| gptkbp:relatedTo |
gptkb:Right_to_Try_Act
clinical trials |
| gptkbp:requires |
informed consent
institutional review board approval manufacturer agreement no comparable or satisfactory alternative therapy physician supervision |
| gptkbp:bfsParent |
gptkb:Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
4
|