Risk Evaluation and Mitigation Strategies (REMS)

URI: https://gptkb.org/entity/Risk_Evaluation_and_Mitigation_Strategies_(REMS)
GPTKB entity
Statements (23)
Predicate Object
gptkbp:instanceOf gptkb:Drug_safety_program
gptkbp:administeredBy gptkb:U.S._Food_and_Drug_Administration
gptkbp:appliesTo biologics
generic drugs
innovator drugs
certain prescription drugs
gptkbp:canBeRequiredAfter drug approval
gptkbp:canBeRequiredAt drug approval
gptkbp:establishedBy gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
gptkbp:goal minimize risk of serious adverse events
gptkbp:mayInclude medication guides
communication plans
implementation systems
elements to assure safe use (ETASU)
gptkbp:monitors gptkb:FDA
gptkbp:notableRelease gptkb:FDA
gptkbp:purpose ensure that the benefits of a drug outweigh its risks
gptkbp:requires drugs with serious safety concerns
gptkbp:reviewedBy gptkb:FDA_Center_for_Biologics_Evaluation_and_Research
gptkb:FDA_Center_for_Drug_Evaluation_and_Research
gptkbp:bfsParent gptkb:U.S._Food_and_Drug_Administration_(FDA)
gptkbp:bfsLayer 7
https://www.w3.org/2000/01/rdf-schema#label Risk Evaluation and Mitigation Strategies (REMS)