Risk Evaluation and Mitigation [strategie hodnocení a snižování rizika (USA)]

topical
2
Terms

REMS

 

Elements to Assure Safe Use
ETASU

Persistent link   https://www.medvik.cz/link/D000073938
Definition

Strategies required by the US Food and Drug Administration (FDA) Amendments Act of 2007 when a question exists as to whether the benefits of a drug outweigh its risks. These constitute a safety plan with several potential components, including a medication guide, a communication plan, elements to ensure safe use and an implementation system to help guide the prescribers, pharmacists and patients.

DUI
D000073938 MeSH Browser
CUI
M000625026
Previous indexing
Risk Assessment (2009-2017); Risk Management (2008-2017)
History note
2018
Public note
2018

Allowable subheadings

LJ
legislation & jurisprudence
OG
organization & administration 1
ST
standards

N Health Care
N04 Health Services Administration 1 746
N04.452 Organization and Administration 1 546
N04.452.871 Risk Management 237
N04.452.871.715 Risk Assessment 6 035
N04.452.871.758 Risk Evaluation and Mitigation 2
N04.452.871.800 Risk Sharing, Financial 7
N04.452.871.900 Safety Management 356
N06 Environment and Public Health 203
N06.850 Public Health 4 047
N06.850.505 Epidemiologic Measurements 134
N06.850.505.715 Risk Assessment 6 035
N06.850.505.715.250 Adverse Outcome Pathways 2
N06.850.505.715.500 Healthcare Failure Mode and Effect Analysis 3
N06.850.505.715.750 Risk Evaluation and Mitigation 2

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