Office of Regulatory Affairs

E88389

federal field organization office organizational unit

The Office of Regulatory Affairs is the U.S. FDA’s primary field organization responsible for inspecting regulated products and manufacturers, enforcing compliance, and overseeing import operations to protect public health.

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All labels observed (4)

Label	Occurrences
Office of Regulatory Affairs canonical	6
FDA Office of Regulatory Affairs	1
Office of Regulatory Affairs (oversight and coordination role)	1
U.S. Food and Drug Administration Office of Regulatory Affairs	1

How this entity was disambiguated

This entity first appeared as the object of triple T686651 — 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: Office of Regulatory Affairs
Context triple: [Food and Drug Administration, hasDivision, Office of Regulatory Affairs]

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. Center for Biologics Evaluation and Research
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.
C. 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.
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. National Center for Toxicological Research
The National Center for Toxicological Research is a U.S. federal research facility that conducts scientific studies to support the safety evaluation and regulatory decisions of the Food and Drug Administration.
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: Office of Regulatory Affairs
Target entity description: The Office of Regulatory Affairs is the U.S. FDA’s primary field organization responsible for inspecting regulated products and manufacturers, enforcing compliance, and overseeing import operations to protect public health.

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. Center for Biologics Evaluation and Research
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.
C. 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.
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. National Center for Toxicological Research
The National Center for Toxicological Research is a U.S. federal research facility that conducts scientific studies to support the safety evaluation and regulatory decisions of the Food and Drug Administration.
F. None of above. chosen

Statements (47)

Predicate	Object
instanceOf	federal field organization ⓘ office ⓘ organizational unit ⓘ
activity	conducting import operations and examinations ⓘ conducting inspections of domestic facilities ⓘ conducting inspections of foreign facilities ⓘ initiating enforcement actions for non-compliance ⓘ
country	United States of America ⓘ
employer	FDA compliance officers ⓘ FDA field investigators ⓘ linked to: Food and Drug Administration FDA import specialists ⓘ FDA laboratory staff ⓘ
fieldOfWork	food and drug regulation ⓘ inspection and compliance ⓘ public health protection ⓘ regulatory affairs ⓘ
goal	ensure that FDA-regulated products are effective when applicable ⓘ ensure that FDA-regulated products are of high quality ⓘ ensure that FDA-regulated products are properly labeled ⓘ ensure that FDA-regulated products are safe ⓘ
hasRole	primary field organization of the U.S. FDA ⓘ
jurisdiction	United States federal jurisdiction ⓘ linked to: United States federal law
locatedIn	FDA field laboratories ⓘ United States regional and district offices ⓘ
mission	protect public health by ensuring compliance with FDA laws and regulations ⓘ
oversees	FDA district offices and resident posts ⓘ field laboratories that analyze product samples ⓘ import entry review for FDA-regulated products ⓘ
parentOrganization	U.S. Food and Drug Administration ⓘ linked to: Food and Drug Administration
partOf	U.S. Food and Drug Administration ⓘ linked to: Food and Drug Administration
regulates	biologics under FDA jurisdiction ⓘ cosmetics under FDA jurisdiction ⓘ food products under FDA jurisdiction ⓘ human drugs under FDA jurisdiction ⓘ medical devices under FDA jurisdiction ⓘ tobacco products under FDA jurisdiction ⓘ veterinary products under FDA jurisdiction ⓘ
responsibleFor	enforcement of compliance with FDA regulations ⓘ inspection of FDA-regulated manufacturers ⓘ inspection of FDA-regulated products ⓘ oversight of import operations for FDA-regulated products ⓘ protecting public health ⓘ
subjectOf	FDA organizational descriptions ⓘ U.S. federal regulatory guidance documents ⓘ
usesMethod	compliance and enforcement actions ⓘ risk-based inspection planning ⓘ sampling and laboratory analysis ⓘ

How these facts were elicited

Referenced by (9)

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

Food and Drug Administration → hasDivision → Office of Regulatory Affairs ⓘ

White Oak, Maryland → isNearFederalFacility → U.S. Food and Drug Administration Office of Regulatory Affairs ⓘ

linked to: Office of Regulatory Affairs

White Oak Federal Research Center → tenant → Office of Regulatory Affairs ⓘ

Office of Pharmaceutical Quality → worksWith → Office of Regulatory Affairs ⓘ

Office of Compliance → collaboratesWith → Office of Regulatory Affairs ⓘ

Office of Compliance and Biologics Quality → collaboratesWith → Office of Regulatory Affairs ⓘ

FDA field laboratories → partOf → FDA Office of Regulatory Affairs ⓘ

linked to: Office of Regulatory Affairs

U.S. Food and Drug Administration Office of the Commissioner → hasComponent → Office of Regulatory Affairs (oversight and coordination role) ⓘ

linked to: Office of Regulatory Affairs

U.S. Food and Drug Administration Office of Regulatory Science → parentOrganization → Office of Regulatory Affairs ⓘ

All labels observed (4)

How this entity was disambiguated Show

Statements (47)

How these facts were elicited Show

Referenced by (9)

How this entity was disambiguated

How these facts were elicited