Triple
T7168846
| Position | Surface form | Disambiguated ID | Type / Status |
|---|---|---|---|
| Subject | Food and Drug Administration Amendments Act of 2007 |
E167140
|
entity |
| Predicate | creates |
P490
|
FINISHED |
| Object |
FDA Risk Evaluation and Mitigation Strategies authority
The FDA Risk Evaluation and Mitigation Strategies authority is the U.S. Food and Drug Administration’s power to require special safety measures and monitoring programs for certain high-risk prescription drugs to ensure their benefits outweigh their risks.
|
E647147
|
NE FINISHED |
How this triple was built (4 steps)
Every LLM step that produced this triple, in pipeline order — named-entity classification, the disambiguation choices (the exact options shown, with the pick highlighted), and the generated description. The batch + timestamp of each is in the Provenance table below.
NER
Named-entity recognition
gpt-5-mini
Instruction
Given a phrase, classify it is english named entity (e.g., persons, organizations, works of art) in Latin script, or not (e.g., literals, dates, URLs, verbose phrases). For disambiguation, the statement where the phrase occurs as object is also given. Please return a JSON object with `phrase` (string, the phrase being analyzed) and `is_ne` (boolean, indicating whether the phrase is a Named Entity).
Input
Phrase: FDA Risk Evaluation and Mitigation Strategies authority | Statement: [Food and Drug Administration Amendments Act of 2007, creates, FDA Risk Evaluation and Mitigation Strategies authority]
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: FDA Risk Evaluation and Mitigation Strategies authority Context triple: [Food and Drug Administration Amendments Act of 2007, creates, FDA Risk Evaluation and Mitigation Strategies authority]
-
A.
Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
The Pharmacovigilance Risk Assessment Committee within the European Medicines Agency is an expert body responsible for evaluating and monitoring the safety of medicines across the European Union and providing recommendations on managing and communicating medicine-related risks.
-
B.
Food and Drug Administration Safety and Innovation Act of 2012
The Food and Drug Administration Safety and Innovation Act of 2012 is a U.S. federal law that reauthorized and expanded FDA user fee programs while enhancing the agency’s authority over drug and medical device safety, innovation, and supply chain oversight.
-
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.
Conditional Marketing Authorization by European Medicines Agency
Conditional Marketing Authorization by the European Medicines Agency is a fast-track regulatory pathway that allows earlier approval of medicines, such as COVID-19 vaccines, based on less comprehensive data than normally required, provided that the benefits outweigh the risks and additional data will be supplied post-approval.
-
E.
Pharmacovigilance Risk Assessment Committee
The Pharmacovigilance Risk Assessment Committee is a scientific body responsible for evaluating and monitoring the safety of human medicines and advising on risk management measures in the European Union.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NEDg
Description generation
gpt-5.1
Instruction
Generate a one-sentence description of the target entity. You are given a context triple in the form (subject, predicate, object), where the object is the target entity. # Instructions Use the triple to infer relevant information about the entity. Describe the entity based on what is most defining, well-known. Avoid repeating the information from the triple, unless really essential. # Response Format Return only the sentence: "Description: [one-sentence description of the target entity]"
Input
Entity: FDA Risk Evaluation and Mitigation Strategies authority Triple: [Food and Drug Administration Amendments Act of 2007, creates, FDA Risk Evaluation and Mitigation Strategies authority]
Generated description
The FDA Risk Evaluation and Mitigation Strategies authority is the U.S. Food and Drug Administration’s power to require special safety measures and monitoring programs for certain high-risk prescription drugs to ensure their benefits outweigh their risks.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: FDA Risk Evaluation and Mitigation Strategies authority Target entity description: The FDA Risk Evaluation and Mitigation Strategies authority is the U.S. Food and Drug Administration’s power to require special safety measures and monitoring programs for certain high-risk prescription drugs to ensure their benefits outweigh their risks.
-
A.
Pharmacovigilance Risk Assessment Committee within the European Medicines Agency
The Pharmacovigilance Risk Assessment Committee within the European Medicines Agency is an expert body responsible for evaluating and monitoring the safety of medicines across the European Union and providing recommendations on managing and communicating medicine-related risks.
-
B.
Food and Drug Administration Safety and Innovation Act of 2012
The Food and Drug Administration Safety and Innovation Act of 2012 is a U.S. federal law that reauthorized and expanded FDA user fee programs while enhancing the agency’s authority over drug and medical device safety, innovation, and supply chain oversight.
-
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.
Conditional Marketing Authorization by European Medicines Agency
Conditional Marketing Authorization by the European Medicines Agency is a fast-track regulatory pathway that allows earlier approval of medicines, such as COVID-19 vaccines, based on less comprehensive data than normally required, provided that the benefits outweigh the risks and additional data will be supplied post-approval.
-
E.
Pharmacovigilance Risk Assessment Committee
The Pharmacovigilance Risk Assessment Committee is a scientific body responsible for evaluating and monitoring the safety of human medicines and advising on risk management measures in the European Union.
- F. None of above. chosen
Provenance (5 batches)
The batch behind each pipeline step, in order, with when it ran. Timestamps are batch-level — stages were processed in waves, so the object chain (NER → NED1 → NEDg → NED2) reads in order, but predicate / elicitation batches can sit in a different wave.
| Step | Stage | Batch ID | Status | When |
|---|---|---|---|---|
| creating | Elicitation | batch_69c68888c10c819095e0383020225758 |
completed | March 27, 2026, 1:39 p.m. |
| NER | Named-entity recognition | batch_69c6e85c606081909f76d76fc5b90bc8 |
completed | March 27, 2026, 8:28 p.m. |
| NED1 | Entity disambiguation (via context triple) | batch_69c7b9094a8c81909e9d5b91ec714831 |
completed | March 28, 2026, 11:18 a.m. |
| NEDg | Description generation | batch_69c7b9e55f84819099af471a65bb68aa |
completed | March 28, 2026, 11:22 a.m. |
| NED2 | Entity disambiguation (via description) | batch_69c7ba9317548190946e21c2731d58a7 |
completed | March 28, 2026, 11:25 a.m. |
Created at: March 27, 2026, 2:48 p.m.