REMS，即"Risk Evaluation and Mitigation Strategy"的缩写，直译为“风险评估和缓解策略”。这个术语在英语中广泛应用于风险管理和控制领域，尤其在涉及药物治疗的安全性评估中发挥着重要作用。其目标是确保在使用某些药物时，风险被准确评估并采取适当的措施来减轻潜在的危害。REMS的英文缩写词本身代表了一套...
remsriskmitigation减灾evaluationstrategy InitialREMSapproved:4/2014 BLASTN-125431TANZEUM TM (Albiglutide) Glucagon-likePeptide-1(GLP-1)ReceptorAgonist GlaxoSmithKlineLLC RISKEVALUATIONANDMITIGATIONSTRATEGY(REMS) GlaxoSmithKline 5MooreDrive,POBox13398 ResearchTrianglePark,NC27709-3398,USA Telephone:1-888-825-5249...
风险减轻策略Riskandrisk减轻策略评估和风险评价和 系统标签: riskmitigationremsstrategiesevaluation策略 RiskEvaluationand MitigationStrategies (REMS) RachelBohard,PharmDCandidate Objectives •DefineREMS. •UnderstandtheevolutionofREMS. •DescribecomponentsofREMS. •ListthefactorsconsideredbytheFDAwhen assessing...
A REMS programneeds to havea risk mitigation strategy. In other words, a plan of what the program is looking to achieve and how it will do so. It will also detail any requirements — for both manufacturers and REMS participants — and materials needed to facilitate the program. To ensure ...
The US Food and Drug Administration can require risk evaluation and mitigation strategy (REMS) programs for prescription drugs to ensure the benefits of use outweigh the risks. We conducted a national survey of physicians' experiences prescribing eight REMS‐covered drugs: (1) ambrisentan; (2)...
The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require drug sponsors to submit a risk evaluation and mitigation strategies (REMS) program for those medicines with serious risks such that failure to effectively manage these risks would tip the benefit-risk bala...
1 As noted, REMS may result in significantly more work for prescribers and dispensers of drugs with REMS, making it less likely for a drug with a complex strategy to be used. Results Impact of Risk Evaluation and Mitigation Strategies in Oncology By Jessica DeMartino, PhD from the NCCN ...
Three years ago, Congress passed the FDA Amendments Act, which empowered the FDA to require Risk Evaluation and Mitigation Strategies (REMS) for new and existing products. The number of REMS required for products has steadily grown since the first programs were introduced in 2008. ...
Risk Evaluation and Mitigation Strategy (REMS): A Short CritiquePeppin, J FPeppin, J.F. (2010). Risk evaluation and mitigation strategy (REMS): a short critique. Medscape.
www.kancaimi.cn|基于 1 个网页 3. 风险减缓策略 此外,自去年发生了两项重大的天灾之后,公司对风险减缓策略(risk mitigation strategy)的意识逐渐提高,这其中包括重新 … niklus.blogspot.com|基于 1 个网页 更多释义 例句