FDA Center for Biologics Evaluation and Research
GPTKB entity
Statements (30)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:government_agency
|
| gptkbp:abbreviation |
gptkb:CBER
|
| gptkbp:collaboratesWith |
gptkb:Centers_for_Disease_Control_and_Prevention
gptkb:National_Institutes_of_Health |
| gptkbp:country |
gptkb:United_States
|
| gptkbp:director |
gptkb:Peter_Marks
|
| gptkbp:division |
gptkb:U.S._Department_of_Health_and_Human_Services
|
| gptkbp:established |
1988
|
| gptkbp:headquartersLocation |
gptkb:Silver_Spring,_Maryland
|
| https://www.w3.org/2000/01/rdf-schema#label |
FDA Center for Biologics Evaluation and Research
|
| gptkbp:mission |
to ensure the safety, purity, potency, and effectiveness of biological products
|
| gptkbp:oversees |
biologics license applications (BLAs)
post-market surveillance of biologics investigational new drug applications (INDs) for biologics |
| gptkbp:parentOrganization |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:regulates |
allergenics
plasma derivatives monoclonal antibodies xenotransplantation products human cells, tissues, and cellular and tissue-based products (HCT/Ps) |
| gptkbp:responsibleFor |
regulation of vaccines
regulation of biological products regulation of blood products regulation of cellular therapies regulation of gene therapies regulation of tissue products |
| gptkbp:website |
https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber
|
| gptkbp:bfsParent |
gptkb:Investigational_New_Drug_applications
gptkb:REMS |
| gptkbp:bfsLayer |
6
|