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.

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All labels observed (8)

Label	Occurrences
Risk Evaluation and Mitigation Strategies	2
FDA Risk Evaluation and Mitigation Strategies authority canonical	1
Food and Drug Administration Amendments Act Risk Evaluation and Mitigation Strategies authority	1
REMS program	1
REMS program in the United States	1
Risk Evaluation and Mitigation Strategies (REMS)	1
Risk Evaluation and Mitigation Strategies program	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 ⓘ
basedOn	Food and Drug Administration Amendments Act of 2007 ⓘ
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 ⓘ Center for Drug Evaluation and Research ⓘ U.S. Food and Drug Administration ⓘ linked to: Food and Drug Administration
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 ⓘ linked to: FDA Risk Evaluation and Mitigation Strategies authority
jurisdiction	United States ⓘ linked to: United States of America
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

Referenced by (9)

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 ⓘ

thalidomide → riskManagementProgramName → Thalomid REMS ⓘ