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

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.

FDA officials discussed how the agency is enhancing its framework for benefit-risk assessment at a 16 May public meeting convened by the Duke Margolis Center for Health Policy, where they...