Center for Biologics Evaluation and Research
E86214
The Center for Biologics Evaluation and Research is the U.S. regulatory body responsible for overseeing the safety, efficacy, and quality of biological products such as vaccines, blood products, and gene therapies.
Aliases (3)
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
U.S. Food and Drug Administration center
→
regulatory agency → |
| collaboratesWith |
Centers for Disease Control and Prevention
→
National Institutes of Health → World Health Organization → |
| conducts |
regulatory science research on biologics
→
|
| country |
United States
→
|
| foundedBy |
U.S. federal government
→
|
| hasDivision |
Office of Biostatistics and Pharmacovigilance
→
Office of Blood Research and Review → Office of Compliance and Biologics Quality → Office of Tissues and Advanced Therapies → Office of Vaccines Research and Review → |
| headquartersFacility |
FDA White Oak Campus
→
|
| headquartersLocation |
Silver Spring, Maryland
NERFINISHED
→
|
| issues |
biologics regulations and policies
→
guidance documents for industry on biologics → |
| jurisdiction |
United States
→
|
| language |
English
→
|
| mission |
to ensure the safety, purity, potency, and effectiveness of biological products
→
to protect and advance public health through regulation of biologics → |
| monitors |
adverse events related to blood products
→
adverse events related to gene therapies → adverse events related to vaccines → |
| oversees |
biologics license applications
→
blood establishment licensing → good manufacturing practice compliance for biologics → investigational new drug applications for biologics → post-market surveillance of biologics → pre-market review of biologics → vaccine safety monitoring → |
| parentOrganization |
U.S. Department of Health and Human Services
→
U.S. Food and Drug Administration → |
| partOf |
U.S. Public Health Service
→
|
| regulates |
allergenics
→
biological products → blood products → cellular therapies → certain diagnostic tests for blood safety → certain medical devices related to blood and tissues → gene therapies → plasma-derived products → tissue-based products → vaccines → xenotransplantation products → |
| shortName |
CBER
→
|
| website |
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber
→
|
Referenced by (5)
| Subject (surface form when different) | Predicate |
|---|---|
|
Center for Biologics Evaluation and Research
("Office of Vaccines Research and Review")
→
Center for Biologics Evaluation and Research ("Office of Blood Research and Review") → Food and Drug Administration → |
hasDivision |
|
Center for Drug Evaluation and Research
→
|
collaboratesWith |
|
Center for Biologics Evaluation and Research
("CBER")
→
|
shortName |