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	11
FDA Center for Biologics Evaluation and Research	2
CBER	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

How this entity was disambiguated

This entity first appeared as the object of triple T686645 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.

NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07

Target entity: Center for Biologics Evaluation and Research
Context triple: [Food and Drug Administration, hasDivision, Center for Biologics Evaluation and Research]

A. Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research is the U.S. FDA division responsible for overseeing the safety, effectiveness, and quality of prescription and over-the-counter drugs.
B. Food and Drug Administration
The Food and Drug Administration is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other consumer products.
C. Center for Scientific Review
The Center for Scientific Review is the National Institutes of Health component responsible for overseeing the peer review of most grant applications to ensure scientific merit and integrity in funding decisions.
D. National Institutes of Health
The National Institutes of Health is the United States’ primary federal biomedical research agency, supporting and conducting medical research to improve public health.
E. National Center for Advancing Translational Sciences
The National Center for Advancing Translational Sciences is a U.S. biomedical research center focused on accelerating the development and delivery of new diagnostics, treatments, and cures by improving the translational science process.
F. None of above. chosen
G. Unsure - the case is ambiguous/there is not enough information to decide.

NED2 Entity disambiguation (via description) gpt-5-mini-2025-08-07

Target entity: Center for Biologics Evaluation and Research
Target entity description: 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.

A. Center for Drug Evaluation and Research
The Center for Drug Evaluation and Research is the U.S. FDA division responsible for overseeing the safety, effectiveness, and quality of prescription and over-the-counter drugs.
B. Food and Drug Administration
The Food and Drug Administration is a U.S. federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other consumer products.
C. Center for Scientific Review
The Center for Scientific Review is the National Institutes of Health component responsible for overseeing the peer review of most grant applications to ensure scientific merit and integrity in funding decisions.
D. National Institutes of Health
The National Institutes of Health is the United States’ primary federal biomedical research agency, supporting and conducting medical research to improve public health.
E. National Center for Advancing Translational Sciences
The National Center for Advancing Translational Sciences is a U.S. biomedical research center focused on accelerating the development and delivery of new diagnostics, treatments, and cures by improving the translational science process.
F. None of above. chosen

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

How these facts were elicited

Referenced by (17)

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 → CBER ⓘ

linked to: Center for Biologics Evaluation and Research

Center for Biologics Evaluation and Research → hasDivision → Office of Vaccines Research and Review ⓘ

linked to: Center for Biologics Evaluation and Research

Center for Biologics Evaluation and Research → hasDivision → Office of Blood Research and Review ⓘ

linked to: Center for Biologics Evaluation and Research

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

linked to: Center for Biologics Evaluation and Research

White Oak, Maryland → isNearFederalFacility → U.S. Food and Drug Administration Center for Biologics Evaluation and Research ⓘ

linked to: 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 ⓘ

Public Law 97-414 → regulatoryBody → Center for Biologics Evaluation and Research ⓘ

Food and Drug Administration Safety and Innovation Act of 2012 → affectsAgency → Center for Biologics Evaluation and Research ⓘ

FDA Risk Evaluation and Mitigation Strategies authority → exercisedBy → Center for Biologics Evaluation and Research ⓘ

U.S. Food and Drug Administration Office of Medical Products and Tobacco → oversees → Center for Biologics Evaluation and Research ⓘ

U.S. Food and Drug Administration Office of Pediatric Therapeutics → collaboratesWith → FDA Center for Biologics Evaluation and Research ⓘ

linked to: Center for Biologics Evaluation and Research

All labels observed (6)

How this entity was disambiguated Show

Statements (47)

How these facts were elicited Show

Referenced by (17)

How this entity was disambiguated

How these facts were elicited