Statements (24)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:Risk_Evaluation_and_Mitigation_Strategy
|
| gptkbp:administeredBy |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:appliesTo |
biologics
generic drugs certain prescription drugs |
| gptkbp:goal |
minimize risk of serious adverse events
|
| https://www.w3.org/2000/01/rdf-schema#label |
REMS
|
| 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 benefits of a drug outweigh its risks
|
| gptkbp:requires |
gptkb:FDA_Amendments_Act_of_2007
monitoring requirements restricted distribution patient enrollment pharmacy certification prescriber training |
| gptkbp:usedIn |
gptkb:United_States
|
| gptkbp:bfsParent |
gptkb:Rover_Environmental_Monitoring_Station
gptkb:NASA_Mars_mission |
| gptkbp:bfsLayer |
5
|