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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Observed surface forms (1)

Surface form	Occurrences
Thalomid REMS	1

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 ⓘ

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 ⓘ

thalidomide → riskManagementProgramName → FDA Risk Evaluation and Mitigation Strategies authority ⓘ

this entity surface form: Thalomid REMS