REMS (Risk Evaluation and Mitigation Strategy)
GPTKB entity
Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Drug safety program
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
Biologics
Certain prescription drugs |
| 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 |
REMS (Risk Evaluation and Mitigation Strategy)
|
| gptkbp:mayInclude |
Communication plans
Elements to assure safe use Implementation system Medication guides |
| gptkbp:monitors |
gptkb:FDA
|
| gptkbp:purpose |
Ensure benefits of a drug outweigh its risks
|
| gptkbp:requires |
Drug dispensing restrictions
FDA for specific drugs Healthcare provider training Patient enrollment Pharmacy certification |
| gptkbp:reviewedBy |
FDA Office of New Drugs
FDA Office of Surveillance and Epidemiology |
| gptkbp:website |
https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems
|
| gptkbp:bfsParent |
gptkb:lenalidomide
|
| gptkbp:bfsLayer |
7
|