FDA Expanded Access (Compassionate Use)
GPTKB entity
Statements (22)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory program
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:alsoKnownAs |
Compassionate Use
|
| gptkbp:appliesTo |
investigational drugs
patients with no comparable or satisfactory alternative therapy investigational biologics investigational medical devices |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:criteria |
expanded access will not interfere with clinical trials
potential patient benefit justifies potential risks |
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Expanded Access (Compassionate Use)
|
| gptkbp:includes |
individual patient access
intermediate-size patient population access treatment IND or protocol for widespread use |
| gptkbp:legalBasis |
21 CFR 312.300-320
|
| gptkbp:purpose |
provide investigational drugs to patients with serious or life-threatening conditions
|
| gptkbp:requires |
gptkb:FDA_authorization
physician request Institutional Review Board (IRB) approval |
| gptkbp:website |
https://www.fda.gov/news-events/public-health-focus/expanded-access
|
| gptkbp:bfsParent |
gptkb:Right_to_Try_law
|
| gptkbp:bfsLayer |
7
|