Risk Evaluation and Mitigation Strategies (REMS)
GPTKB entity
Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
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
|
| https://www.w3.org/2000/01/rdf-schema#label |
Risk Evaluation and Mitigation Strategies (REMS)
|
| 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
|