Risk Evaluation and Mitigation Strategy
GPTKB entity
Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory process
|
| gptkbp:abbreviation |
gptkb:REMS
|
| gptkbp:appliesTo |
biologics
generic drugs innovator drugs certain prescription drugs |
| gptkbp:canBeRequiredAfter |
drug is on the market
|
| gptkbp:canBeRequiredAt |
time of drug approval
|
| gptkbp:goal |
minimize risk of serious adverse events
improve safe use of medications |
| https://www.w3.org/2000/01/rdf-schema#label |
Risk Evaluation and Mitigation Strategy
|
| gptkbp:mayInclude |
medication guides
communication plans elements to assure safe use implementation system |
| gptkbp:purpose |
ensure benefits of a drug outweigh its risks
|
| gptkbp:regulates |
gptkb:U.S._Food_and_Drug_Administration
|
| gptkbp:requires |
gptkb:FDA_Amendments_Act_of_2007
|
| gptkbp:reviewedBy |
gptkb:FDA_Center_for_Biologics_Evaluation_and_Research
gptkb:FDA_Center_for_Drug_Evaluation_and_Research |
| gptkbp:usedIn |
gptkb:United_States
|
| gptkbp:bfsParent |
gptkb:REMS
|
| gptkbp:bfsLayer |
6
|