Statements (19)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
compassionate use program
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:alsoKnownAs |
gptkb:compassionate_use
|
| gptkbp:appliesTo |
patients who lack alternative therapies
|
| gptkbp:country |
gptkb:United_States
|
| gptkbp:established |
1987
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA expanded access program
|
| gptkbp:includes |
individual patient access
intermediate-size patient population access treatment IND or protocol |
| gptkbp:legalBasis |
gptkb:21_CFR_312.300
|
| gptkbp:purpose |
provide investigational drugs to patients with serious or life-threatening conditions
|
| gptkbp:regulates |
access to investigational drugs, biologics, and medical devices
|
| gptkbp:relatedTo |
gptkb:Right_to_Try_Act
|
| gptkbp:requires |
gptkb:FDA_authorization
institutional review board approval physician request |
| gptkbp:bfsParent |
gptkb:Right_to_Try_Act
|
| gptkbp:bfsLayer |
6
|