Investigational new drug applications
GPTKB entity
Statements (14)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:abbreviation |
IND
|
| gptkbp:country |
gptkb:United_States
|
| https://www.w3.org/2000/01/rdf-schema#label |
Investigational new drug applications
|
| gptkbp:includes |
clinical protocols
manufacturing information preclinical data |
| gptkbp:precededBy |
gptkb:New_Drug_Application
|
| gptkbp:purpose |
obtain permission to start clinical trials
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
clinical trials
|
| gptkbp:requires |
new drug candidates
|
| gptkbp:bfsParent |
gptkb:21_U.S.C._355(i)
|
| gptkbp:bfsLayer |
7
|