Office of Regulatory Affairs
E88389
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.
All labels observed (3)
| Label | Occurrences |
|---|---|
| Office of Regulatory Affairs canonical | 5 |
| FDA Office of Regulatory Affairs | 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
ⓘ
Food and Drug Administration ⓘ
surface form:
FDA field investigators
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 law
ⓘ
surface form:
United States federal jurisdiction
|
| 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 |
Food and Drug Administration
ⓘ
surface form:
U.S. Food and Drug Administration
|
| partOf |
Food and Drug Administration
ⓘ
surface form:
U.S. 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
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Office of Regulatory Affairs Description of subject: 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.
Referenced by (7)
Full triples — surface form annotated when it differs from this entity's canonical label.
this entity surface form:
U.S. Food and Drug Administration Office of Regulatory Affairs
this entity surface form:
FDA Office of Regulatory Affairs