Anyone who has been through a benefits assessment and then waited to hear the decision will know the stress it can cause. The process has been found to create a lack of trust and impact negatively on ...
The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a ...
The drug development process necessitates the comprehensive evaluation of a candidate’s therapeutic benefits alongside its potential risks. Benefit–risk assessments are central to this endeavour, ...
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