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US FDA's Benefit-Risk Assessment Could Include More Emphasis on Patient Involvement

 
• By Brenda Sandburg

Agency aims to centralize and better communicate its assessments; stakeholders discuss involving patients early in drug development and offer suggestions for 2020 draft guidance.

Balance with risk benefit, pros and cons, 3d render illustration

The US Food and Drug Administration's development of a new approach to assessing the benefits and risks of drugs throughout their life cycle dovetails with efforts to better integrate patient feedback into product review and development.

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