Risk Evaluation and Mitigation

Riskutvärdering och begränsningsstrategier

Engelsk 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.

Svenska synonymer

Inga svenska synonymer finns.

Engelska synonymer

Elements to Assure Safe Use ETASU