Biologics License Applications (BLA)
GPTKB entity
Statements (20)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
submission
|
| gptkbp:application |
biologic product manufacturer
|
| gptkbp:appliesTo |
biological products
|
| gptkbp:approvedBy |
licensure to market biologic product in the U.S.
|
| gptkbp:governedBy |
gptkb:Public_Health_Service_Act
|
| https://www.w3.org/2000/01/rdf-schema#label |
Biologics License Applications (BLA)
|
| gptkbp:includes |
clinical data
labeling information manufacturing information |
| gptkbp:mayInclude |
post-marketing requirements
risk evaluation and mitigation strategies |
| gptkbp:purpose |
to demonstrate safety, purity, and potency of biologic products
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:relatedTo |
New Drug Application (NDA)
|
| gptkbp:requires |
marketing of biologics in the United States
|
| gptkbp:reviewedBy |
gptkb:Center_for_Biologics_Evaluation_and_Research
Center for Drug Evaluation and Research |
| gptkbp:YouTubeChannel |
pre-market approval
|
| gptkbp:bfsParent |
gptkb:U.S._Food_and_Drug_Administration_(FDA)
|
| gptkbp:bfsLayer |
7
|