Investigational New Drug (IND) applications
GPTKB entity
Statements (49)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
submission
|
| gptkbp:application |
gptkb:biotechnology
gptkb:educational_institution gptkb:government_agency individual investigator |
| gptkbp:canBe |
commercial IND
emergency use IND research IND treatment IND |
| gptkbp:canBeSubmitted |
electronically
in paper format |
| gptkbp:cause |
New Drug Application (NDA)
|
| gptkbp:contains |
chemistry, manufacturing, and controls (CMC) information
clinical study protocols informed consent forms institutional review board (IRB) approval investigator brochure pharmacology and toxicology data |
| gptkbp:filingDate |
promoter
|
| https://www.w3.org/2000/01/rdf-schema#label |
Investigational New Drug (IND) applications
|
| gptkbp:includes |
clinical protocols
manufacturing information preclinical data investigator information |
| gptkbp:legalBasis |
gptkb:21_CFR_Part_312
|
| gptkbp:purpose |
obtain authorization to administer an investigational drug to humans
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
biologics
biosimilars gene therapies vaccines small molecule drugs cell therapies clinical trials in the United States Phase 1 clinical trials |
| gptkbp:reviewedBy |
gptkb:FDA_Center_for_Biologics_Evaluation_and_Research
gptkb:FDA_Center_for_Drug_Evaluation_and_Research |
| gptkbp:reviewPeriod |
30 days
|
| gptkbp:status |
active
terminated inactive withdrawn |
| gptkbp:subject |
annual reporting requirements
FDA inspections Good Clinical Practice guidelines safety reporting requirements |
| gptkbp:type |
clinical hold
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|