Office of Orphan Products Development
E642117
The Office of Orphan Products Development is a U.S. Food and Drug Administration office that promotes the development of drugs and other medical products for rare diseases and conditions.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Office of Orphan Products Development canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T7110895 — 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 Orphan Products Development Context triple: [Orphan Drug Act of 1983, administeredBy, Office of Orphan Products Development]
-
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.
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B.
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.
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C.
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.
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D.
Office of Rare Diseases Research
The Office of Rare Diseases Research is a U.S. government program that coordinates and supports research, information, and collaboration efforts focused on rare diseases.
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E.
Office of Pharmaceutical Quality
The Office of Pharmaceutical Quality is a U.S. Food and Drug Administration office responsible for ensuring the quality, safety, and consistency of human drugs throughout their lifecycle.
- 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 Orphan Products Development Target entity description: The Office of Orphan Products Development is a U.S. Food and Drug Administration office that promotes the development of drugs and other medical products for rare diseases and conditions.
-
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.
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.
-
C.
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.
-
D.
Office of Rare Diseases Research
The Office of Rare Diseases Research is a U.S. government program that coordinates and supports research, information, and collaboration efforts focused on rare diseases.
-
E.
Office of Pharmaceutical Quality
The Office of Pharmaceutical Quality is a U.S. Food and Drug Administration office responsible for ensuring the quality, safety, and consistency of human drugs throughout their lifecycle.
- F. None of above. chosen
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
FDA office
ⓘ
government organization ⓘ public health agency unit ⓘ |
| administers |
Humanitarian Use Device designation program
ⓘ
Orphan Drug Designation program NERFINISHED ⓘ Orphan Products Grants Program NERFINISHED ⓘ pediatric device consortia grants related to rare diseases ⓘ |
| collaboratesWith |
academic researchers in rare disease fields
ⓘ
patient advocacy organizations for rare diseases ⓘ pharmaceutical companies developing orphan drugs ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| field |
medical product development
ⓘ
orphan drugs ⓘ public health ⓘ rare diseases ⓘ regulatory affairs ⓘ |
| focusesOn |
biological products for rare diseases
ⓘ
drugs for rare diseases ⓘ humanitarian use devices ⓘ medical devices for rare conditions ⓘ orphan products ⓘ rare diseases ⓘ |
| goal |
to encourage innovation in orphan product development
ⓘ
to facilitate patient access to therapies for rare diseases ⓘ |
| grants |
humanitarian use device designations
ⓘ
orphan drug designations ⓘ |
| industry |
biotechnology industry
ⓘ
medical devices ⓘ pharmaceutical industry ⓘ |
| jurisdiction |
United States government
ⓘ
surface form:
United States federal government
|
| legalBasis | Orphan Drug Act NERFINISHED ⓘ |
| locatedIn |
Maryland
ⓘ
Silver Spring, Maryland NERFINISHED ⓘ United States of America ⓘ
surface form:
United States
|
| mission |
to administer incentives for orphan product development
ⓘ
to promote the development of products for the diagnosis, prevention, and treatment of rare diseases and conditions ⓘ |
| parentOrganization |
U.S. Department of Health and Human Services
NERFINISHED
ⓘ
U.S. Food and Drug Administration NERFINISHED ⓘ |
| partOf |
U.S. Department of Health and Human Services
NERFINISHED
ⓘ
U.S. Food and Drug Administration NERFINISHED ⓘ |
| provides |
incentives for sponsors to develop treatments for rare diseases
ⓘ
regulatory guidance for orphan product development ⓘ research grants for clinical studies of orphan products ⓘ |
| regulates | orphan-designated drugs in coordination with FDA review centers ⓘ |
| supports |
development of biologics for rare diseases
ⓘ
development of diagnostics for rare diseases ⓘ development of drugs for rare diseases ⓘ development of medical devices for rare conditions ⓘ |
| website | https://www.fda.gov/about-fda/office-clinical-policy-and-programs/office-orphan-products-development ⓘ |
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 Orphan Products Development Description of subject: The Office of Orphan Products Development is a U.S. Food and Drug Administration office that promotes the development of drugs and other medical products for rare diseases and conditions.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.