Statements (21)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:Risk_Evaluation_and_Mitigation_Strategy
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
certain prescription drugs
|
| gptkbp:country |
gptkb:United_States
|
| gptkbp:establishedBy |
gptkb:Food_and_Drug_Administration_Amendments_Act_of_2007
|
| https://www.w3.org/2000/01/rdf-schema#label |
REMS program in the US
|
| gptkbp:mayInclude |
medication guides
communication plans elements to assure safe use implementation systems |
| gptkbp:monitors |
gptkb:FDA_Center_for_Biologics_Evaluation_and_Research
gptkb:FDA_Center_for_Drug_Evaluation_and_Research |
| gptkbp:purpose |
ensure that the benefits of a drug outweigh its risks
|
| gptkbp:requires |
restricted distribution
patient enrollment pharmacy certification drugs with serious safety concerns prescriber certification |
| gptkbp:website |
https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/risk-evaluation-and-mitigation-strategies-rems
|
| gptkbp:bfsParent |
gptkb:clozapine
|
| gptkbp:bfsLayer |
6
|