PubMed

將患者關於益處和風險的偏好融入醫療技術監管評估框架的框架。

PMID：27712701 · 2016

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期刊Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

年份2016

PMID27712701

摘要

In response to 2012 guidance in which the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) stated the importance of patient-centric measures in regulatory benefit-risk assessments, the Medical Device Innovation Consortium (MDIC) initiated a project. The project was used to develop a framework to help the Food and Drug Administration (FDA) and industry sponsors understand how patient preferences regarding benefit and risk might be integrated into the revie

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