Center for Biologics Evaluation and Research

E86214

U.S. Food and Drug Administration center regulatory agency

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.

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All labels observed (6)

Label	Occurrences
Center for Biologics Evaluation and Research canonical	7
CBER	1
FDA Center for Biologics Evaluation and Research	1
Office of Blood Research and Review	1
Office of Vaccines Research and Review	1
U.S. Food and Drug Administration Center for Biologics Evaluation and Research	1

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 of America ⓘ surface form: United States
foundedBy	United States government ⓘ surface form: U.S. federal government
hasDivision	Office of Biostatistics ⓘ surface form: Office of Biostatistics and Pharmacovigilance Center for Biologics Evaluation and Research self-linksurface differs ⓘ surface form: Office of Blood Research and Review Office of Compliance and Biologics Quality ⓘ Office of Tissues and Advanced Therapies ⓘ Center for Biologics Evaluation and Research self-linksurface differs ⓘ surface form: Office of Vaccines Research and Review
headquartersFacility	White Oak Federal Research Center ⓘ surface form: FDA White Oak Campus
headquartersLocation	Silver Spring, Maryland ⓘ
issues	biologics regulations and policies ⓘ guidance documents for industry on biologics ⓘ
jurisdiction	United States of America ⓘ surface form: 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	United States Department of Health and Human Services ⓘ surface form: U.S. Department of Health and Human Services Food and Drug Administration ⓘ surface form: U.S. Food and Drug Administration
partOf	Public Health Service ⓘ surface form: 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	Center for Biologics Evaluation and Research self-linksurface differs ⓘ surface form: CBER
website	https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber ⓘ

Referenced by (12)

Full triples — surface form annotated when it differs from this entity's canonical label.

Food and Drug Administration → hasDivision → Center for Biologics Evaluation and Research ⓘ

Center for Drug Evaluation and Research → collaboratesWith → Center for Biologics Evaluation and Research ⓘ

Center for Biologics Evaluation and Research → shortName → Center for Biologics Evaluation and Research self-linksurface differs ⓘ

this entity surface form: CBER

Center for Biologics Evaluation and Research → hasDivision → Center for Biologics Evaluation and Research self-linksurface differs ⓘ

this entity surface form: Office of Vaccines Research and Review

Center for Biologics Evaluation and Research → hasDivision → Center for Biologics Evaluation and Research self-linksurface differs ⓘ

this entity surface form: Office of Blood Research and Review

FDA traditional approval → reviewedBy → Center for Biologics Evaluation and Research ⓘ

this entity surface form: FDA Center for Biologics Evaluation and Research

White Oak, Maryland → isNearFederalFacility → Center for Biologics Evaluation and Research ⓘ

this entity surface form: U.S. Food and Drug Administration Center for Biologics Evaluation and Research

White Oak Federal Research Center → tenant → Center for Biologics Evaluation and Research ⓘ

Office of Tissues and Advanced Therapies → partOf → Center for Biologics Evaluation and Research ⓘ

Office of Tissues and Advanced Therapies → parentOrganization → Center for Biologics Evaluation and Research ⓘ

Office of Compliance and Biologics Quality → partOf → Center for Biologics Evaluation and Research ⓘ

Office of Compliance and Biologics Quality → parentOrganization → Center for Biologics Evaluation and Research ⓘ