Um Quadro para Incorporar Preferências do Paciente em Benefícios e Riscos na Avaliação Regulatória de Tecnologias Médicas.
PMID: 27712701 · 2016
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Resumo
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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