Statements (13)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:United_States_federal_law
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
Investigational new drugs
Patients with serious or immediately life-threatening diseases |
| gptkbp:citation |
Federal Register Vol. 74, No. 155
|
| https://www.w3.org/2000/01/rdf-schema#label |
21 CFR 312.300
|
| gptkbp:jurisdiction |
gptkb:United_States
|
| gptkbp:partOf |
gptkb:21_CFR_Part_312
|
| gptkbp:purpose |
To provide a mechanism for patients to access investigational drugs outside of clinical trials
|
| gptkbp:regulates |
Expanded Access to Investigational Drugs for Treatment Use
|
| gptkbp:startDate |
2009-08-13
|
| gptkbp:bfsParent |
gptkb:FDA_expanded_access_program
|
| gptkbp:bfsLayer |
7
|