Office of Tissues and Advanced Therapies
E409911
The Office of Tissues and Advanced Therapies is a U.S. FDA office responsible for regulating cellular and gene therapies, tissue-based products, and other advanced biologic treatments.
All labels observed (2)
How this entity was disambiguated
This entity first appeared as the object of triple T4061237 — 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 Tissues and Advanced Therapies Context triple: [Center for Biologics Evaluation and Research, hasDivision, Office of Tissues and Advanced Therapies]
-
A.
Human Tissue Authority
The Human Tissue Authority is a UK regulatory body responsible for licensing and overseeing the removal, storage, use, and disposal of human bodies, organs, and tissue for purposes such as research, transplantation, and education.
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B.
Committee for Advanced Therapies
The Committee for Advanced Therapies is a scientific body within the European Medicines Agency responsible for evaluating and providing expert opinions on advanced therapy medicinal products such as gene, cell, and tissue-engineered therapies.
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C.
Center for Cellular and Molecular Therapeutics
The Center for Cellular and Molecular Therapeutics is a research institute specializing in developing gene and cell-based therapies for pediatric and genetic diseases.
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D.
NHS Blood and Transplant
NHS Blood and Transplant is a UK special health authority responsible for providing a safe and reliable supply of blood, organs, and associated services to the National Health Service.
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E.
Office of Translational Sciences
The Office of Translational Sciences is a scientific office within the U.S. Food and Drug Administration that advances the translation of biomedical research into safe and effective drug therapies through regulatory science, research, and policy development.
- 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 Tissues and Advanced Therapies Target entity description: The Office of Tissues and Advanced Therapies is a U.S. FDA office responsible for regulating cellular and gene therapies, tissue-based products, and other advanced biologic treatments.
-
A.
Human Tissue Authority
The Human Tissue Authority is a UK regulatory body responsible for licensing and overseeing the removal, storage, use, and disposal of human bodies, organs, and tissue for purposes such as research, transplantation, and education.
-
B.
Committee for Advanced Therapies
The Committee for Advanced Therapies is a scientific body within the European Medicines Agency responsible for evaluating and providing expert opinions on advanced therapy medicinal products such as gene, cell, and tissue-engineered therapies.
-
C.
Center for Cellular and Molecular Therapeutics
The Center for Cellular and Molecular Therapeutics is a research institute specializing in developing gene and cell-based therapies for pediatric and genetic diseases.
-
D.
NHS Blood and Transplant
NHS Blood and Transplant is a UK special health authority responsible for providing a safe and reliable supply of blood, organs, and associated services to the National Health Service.
-
E.
Office of Translational Sciences
The Office of Translational Sciences is a scientific office within the U.S. Food and Drug Administration that advances the translation of biomedical research into safe and effective drug therapies through regulatory science, research, and policy development.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
FDA office
ⓘ
regulatory agency unit ⓘ |
| abbreviation | OTAT ⓘ |
| collaboratesWith |
Centers for Disease Control and Prevention
ⓘ
National Institutes of Health ⓘ academic research institutions ⓘ biotechnology industry ⓘ |
| country |
United States
ⓘ
linked to:
United States of America
|
| employer |
U.S. federal government
ⓘ
linked to:
United States government
|
| field |
cell therapy
ⓘ
gene therapy ⓘ regenerative medicine ⓘ regulatory science ⓘ tissue engineering ⓘ |
| jurisdiction |
Federal Food, Drug, and Cosmetic Act
ⓘ
Public Health Service Act ⓘ United States federal law ⓘ |
| language | English ⓘ |
| locatedIn |
FDA White Oak Campus
ⓘ
linked to:
White Oak Federal Research Center
Silver Spring, Maryland ⓘ |
| mission | to ensure the safety, purity, potency, and effectiveness of tissues and advanced therapies ⓘ |
| parentOrganization |
Center for Biologics Evaluation and Research
ⓘ
U.S. Food and Drug Administration ⓘ
linked to:
Food and Drug Administration
|
| partOf |
Center for Biologics Evaluation and Research
ⓘ
U.S. Food and Drug Administration ⓘ
linked to:
Food and Drug Administration
|
| regulates |
advanced biologic therapies
ⓘ
cellular therapies ⓘ certain devices used with cell and gene therapies ⓘ gene therapies ⓘ gene therapy clinical trials ⓘ human cells, tissues, and cellular and tissue-based products ⓘ somatic cell therapies ⓘ tissue-based products ⓘ xenotransplantation products ⓘ |
| regulatoryScope |
biological products
ⓘ
gene-modified cellular products ⓘ human cells and tissues ⓘ |
| responsibleFor |
development of guidance documents for cell and gene therapies
ⓘ
oversight of hematology-related biologic products ⓘ oversight of oncology-related cell and gene therapies ⓘ oversight of rare disease gene therapies ⓘ oversight of regenerative medicine therapies ⓘ post-market safety surveillance of advanced therapies ⓘ pre-market review of cell and gene therapy products ⓘ review of Biologics License Applications for advanced therapies ⓘ review of Investigational New Drug applications for gene and cell therapies ⓘ |
| sector | public sector ⓘ |
| website |
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/office-tissues-and-advanced-therapies
ⓘ
linked to:
Office of Tissues and Advanced Therapies
|
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 Tissues and Advanced Therapies Description of subject: The Office of Tissues and Advanced Therapies is a U.S. FDA office responsible for regulating cellular and gene therapies, tissue-based products, and other advanced biologic treatments.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
Center for Biologics Evaluation and Research
→
hasDivision
→
Office of Tissues and Advanced Therapies
ⓘ
Office of Tissues and Advanced Therapies
→
website
→
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/office-tissues-and-advanced-therapies
ⓘ
linked to: Office of Tissues and Advanced Therapies