Center for Drug Evaluation and Research

E85252

U.S. Food and Drug Administration center drug regulatory authority component regulatory agency division

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.

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All labels observed (7)

Label	Occurrences
Center for Drug Evaluation and Research canonical	18
Office of New Drugs	4
FDA Center for Drug Evaluation and Research	3
CDER	2
Office of Generic Drugs	1
U.S. Food and Drug Administration Center for Drug Evaluation and Research	1
https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder	1

How this entity was disambiguated

This entity first appeared as the object of triple T686644 — 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 Drug Evaluation and Research
Context triple: [Food and Drug Administration, hasDivision, Center for Drug Evaluation and Research]

A. 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.
B. Committee for Proprietary Medicinal Products
The Committee for Proprietary Medicinal Products was a former scientific committee of the European Union responsible for evaluating and issuing opinions on the quality, safety, and efficacy of human medicinal products before it was replaced by the European Medicines Agency’s current committee structure.
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. Office of Research and Development
The Office of Research and Development is a specialized unit focused on planning, funding, and overseeing scientific and technological research initiatives within its parent organization.
E. Committee for Orphan Medicinal Products
The Committee for Orphan Medicinal Products is a specialized expert body that evaluates and advises on the designation and development of medicines for rare diseases within the European Union.
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 Drug Evaluation and Research
Target entity description: 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.

A. 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.
B. Committee for Proprietary Medicinal Products
The Committee for Proprietary Medicinal Products was a former scientific committee of the European Union responsible for evaluating and issuing opinions on the quality, safety, and efficacy of human medicinal products before it was replaced by the European Medicines Agency’s current committee structure.
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. Office of Research and Development
The Office of Research and Development is a specialized unit focused on planning, funding, and overseeing scientific and technological research initiatives within its parent organization.
E. Committee for Orphan Medicinal Products
The Committee for Orphan Medicinal Products is a specialized expert body that evaluates and advises on the designation and development of medicines for rare diseases within the European Union.
F. None of above. chosen

Statements (49)

Predicate	Object
instanceOf	U.S. Food and Drug Administration center ⓘ drug regulatory authority component ⓘ regulatory agency division ⓘ
abbreviation	CDER ⓘ linked to: Center for Drug Evaluation and Research
collaboratesWith	Center for Biologics Evaluation and Research ⓘ Center for Devices and Radiological Health ⓘ
country	United States of America ⓘ
field	clinical research ⓘ drug regulation ⓘ pharmacology ⓘ public health ⓘ
goal	protect public health by ensuring safe and effective drugs ⓘ provide clear and science-based drug information to the public ⓘ
headquartersLocation	Silver Spring, Maryland ⓘ White Oak Federal Research Center ⓘ
jurisdiction	federal government of the United States ⓘ linked to: United States government
language	English ⓘ
locatedInTimeZone	Eastern Time Zone ⓘ
oversees	Office of Biostatistics ⓘ Office of Compliance ⓘ Office of Generic Drugs ⓘ linked to: Center for Drug Evaluation and Research Office of New Drugs ⓘ linked to: Center for Drug Evaluation and Research Office of Pharmaceutical Quality ⓘ Office of Surveillance and Epidemiology ⓘ Office of Translational Sciences ⓘ
parentOrganization	U.S. Food and Drug Administration ⓘ linked to: Food and Drug Administration
partOf	U.S. Department of Health and Human Services ⓘ linked to: United States Department of Health and Human Services
regulates	biologic drug products shared with CBER ⓘ drug advertising review ⓘ drug labeling ⓘ drug manufacturing quality ⓘ generic drugs ⓘ over-the-counter drugs ⓘ prescription drugs ⓘ therapeutic biologics assigned to CDER ⓘ
responsibleFor	abbreviated new drug application review ⓘ clinical pharmacology and biopharmaceutics review ⓘ drug safety communications ⓘ ensuring effectiveness of human drugs in the United States ⓘ ensuring quality of human drugs in the United States ⓘ ensuring safety of human drugs in the United States ⓘ good manufacturing practice oversight for drugs ⓘ guidance documents for industry on drug development ⓘ new drug application review ⓘ over-the-counter drug monograph system ⓘ postmarketing drug safety surveillance ⓘ risk evaluation and mitigation strategies oversight ⓘ
uses	benefit-risk assessment for drug approvals ⓘ
website	https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder ⓘ linked to: Center for Drug Evaluation and Research

How these facts were elicited

Referenced by (30)

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

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

Center for Drug Evaluation and Research → abbreviation → CDER ⓘ

linked to: Center for Drug Evaluation and Research

Center for Drug Evaluation and Research → oversees → Office of New Drugs ⓘ

linked to: Center for Drug Evaluation and Research

Center for Drug Evaluation and Research → oversees → Office of Generic Drugs ⓘ

linked to: Center for Drug Evaluation and Research

Center for Drug Evaluation and Research → website → https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder ⓘ

linked to: Center for Drug Evaluation and Research

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

linked to: Center for Drug Evaluation and Research

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

linked to: Center for Drug Evaluation and Research

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

Office of Pharmaceutical Quality → partOf → Center for Drug Evaluation and Research ⓘ

Office of Pharmaceutical Quality → parentOrganization → Center for Drug Evaluation and Research ⓘ

Office of Pharmaceutical Quality → worksWith → Office of New Drugs ⓘ

linked to: Center for Drug Evaluation and Research

Office of Surveillance and Epidemiology → partOf → Center for Drug Evaluation and Research ⓘ

Office of Surveillance and Epidemiology → parentAgency → Center for Drug Evaluation and Research ⓘ

Office of Surveillance and Epidemiology → collaboratesWith → Office of New Drugs ⓘ

linked to: Center for Drug Evaluation and Research

Office of Translational Sciences → partOf → Center for Drug Evaluation and Research ⓘ

Office of Translational Sciences → parentOrganization → Center for Drug Evaluation and Research ⓘ

Office of Compliance → partOf → Center for Drug Evaluation and Research ⓘ

Office of Compliance → parentOrganization → Center for Drug Evaluation and Research ⓘ

Office of Biostatistics → partOf → Center for Drug Evaluation and Research ⓘ

Office of Biostatistics → collaboratesWith → Office of New Drugs ⓘ

linked to: Center for Drug Evaluation and Research

National Toxicology Program → cooperatingAgency → Center for Drug Evaluation and Research ⓘ

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

Abbreviated New Drug Application process → jurisdiction → Center for Drug Evaluation and Research ⓘ

Abbreviated New Drug Application process → administeredBy → FDA Center for Drug Evaluation and Research ⓘ

linked to: Center for Drug Evaluation and Research

ANDA → submissionTo → Center for Drug Evaluation and Research ⓘ

ANDA → submissionTo → CDER ⓘ

linked to: Center for Drug Evaluation and Research

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

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

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

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

linked to: Center for Drug Evaluation and Research

All labels observed (7)

How this entity was disambiguated Show

Statements (49)

How these facts were elicited Show

Referenced by (30)

How this entity was disambiguated

How these facts were elicited