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

tematický
2
Termíny

REMS

 

Elements to Assure Safe Use
ETASU

Perzistentní odkaz   https://www.medvik.cz/link/D000073938
Definice

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 Prohlížeč
CUI
M000625026
Předchozí užití
Risk Assessment (2009-2017); Risk Management (2008-2017)
Historická pozn.
2018
Veřejná pozn.
2018