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Abstract:
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The development and implementation of benefit-risk assessment is multi-faceted and should be done throughout the clinical development life cycle. Use of structured benefit-risk framework could enhance regulatory decisions, both in terms of scientific validity and in terms of consistency and transparency to stakeholders. In this talk, we describe five real examples that regulatory agencies considered in benefit-risk evaluations, resulting in different outcomes in their approval and marketing status. These case studies illustrate a few key considerations for a full benefit-risk evaluation.
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