FDA Risk Evaluation and Mitigation Strategies authority
E647147
United States federal regulatory power
drug safety authority
pharmacovigilance tool
regulatory 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.
All labels observed (2)
| Label | Occurrences |
|---|---|
| FDA Risk Evaluation and Mitigation Strategies authority canonical | 1 |
| Thalomid REMS | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T7168846 — 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: 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.
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
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
United States federal regulatory power
ⓘ
drug safety authority ⓘ pharmacovigilance tool ⓘ regulatory authority ⓘ |
| aimsTo |
ensure safe use of high-risk medications
ⓘ
inform patients and providers about serious risks ⓘ |
| allowsFDATo |
enforce compliance with REMS requirements
ⓘ
modify existing REMS requirements ⓘ require a REMS after drug approval ⓘ require a REMS before drug approval ⓘ |
| appliesTo |
biologic products
ⓘ
prescription drugs ⓘ |
| appliesWhen |
FDA determines additional risk mitigation is necessary
ⓘ
a drug has serious safety risks ⓘ |
| authorizedBy | United States Congress NERFINISHED ⓘ |
| basedOn | Food and Drug Administration Amendments Act of 2007 NERFINISHED ⓘ |
| canRequire |
communication plans to healthcare providers
ⓘ
elements to assure safe use ⓘ implementation systems ⓘ medication guides ⓘ patient enrollment in registries ⓘ patient package inserts ⓘ pharmacy certification ⓘ postmarketing safety monitoring ⓘ prescriber certification ⓘ restricted distribution systems ⓘ |
| enforcedBy |
civil monetary penalties
ⓘ
drug misbranding actions ⓘ injunctions ⓘ |
| exercisedBy |
Center for Biologics Evaluation and Research
NERFINISHED
ⓘ
Center for Drug Evaluation and Research NERFINISHED ⓘ U.S. Food and Drug Administration NERFINISHED ⓘ |
| hasPurpose |
ensure that a drug’s benefits outweigh its risks
ⓘ
mitigate serious risks associated with certain medications ⓘ protect public health ⓘ |
| implementedThrough |
REMS programs
ⓘ
Risk Evaluation and Mitigation Strategies NERFINISHED ⓘ |
| jurisdiction |
United States of America
ⓘ
surface form:
United States
|
| relatedTo |
FDA drug safety communications
ⓘ
drug labeling requirements ⓘ postmarketing risk management ⓘ |
| requiresCollaborationFrom |
drug manufacturers
ⓘ
healthcare providers ⓘ pharmacies ⓘ |
| scopeIncludes |
biologics license applications
ⓘ
certain already marketed drugs ⓘ new drug applications ⓘ |
| targets | drugs with known or potential serious risks ⓘ |
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: FDA Risk Evaluation and Mitigation Strategies authority Description of subject: 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.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
Food and Drug Administration Amendments Act of 2007
→
creates
→
FDA Risk Evaluation and Mitigation Strategies authority
ⓘ
this entity surface form:
Thalomid REMS