Investigational New Drug applications
GPTKB entity
Statements (27)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:abbreviation |
IND applications
|
| gptkbp:country |
gptkb:United_States
|
| gptkbp:filingDate |
gptkb:biotechnology
gptkb:research_institute promoter |
| https://www.w3.org/2000/01/rdf-schema#label |
Investigational New Drug applications
|
| gptkbp:includes |
clinical protocols
manufacturing information preclinical data investigator information |
| gptkbp:legalBasis |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
gptkb:21_CFR_Part_312 |
| gptkbp:purpose |
to obtain authorization to administer an investigational drug to humans
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
gptkb:drug
gptkb:New_Drug_Application clinical research drug development |
| gptkbp:requires |
clinical trials in the United States
|
| gptkbp:reviewedBy |
gptkb:FDA_Center_for_Biologics_Evaluation_and_Research
gptkb:FDA_Center_for_Drug_Evaluation_and_Research |
| gptkbp:status |
active
terminated inactive |
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:bfsLayer |
5
|