FDA Quietly Consults Patients To Understand Vimizim's Six-Minute Walk Significance
Meeting with Morquio A patient and caregivers appears to have helped to assuage FDA concerns about clinical relevance of the Vimizim trial’s primary endpoint – and illustrates FDA’s openness to patient input even during specific reviews of new product applications.
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US FDA Sought Patient Viewpoint On Hemlibra's Benefit/Risk Profile
Hemophilia patient advocate expressed concerns to FDA about ability of hemophilia treatment centers to educate patients about thrombotic microangiopathy and thromboembolic events, unexpected but serious cases of which were seen in the clinical program.
FDA Ends Regularly Scheduled Patient-Focused Drug Development Meetings
After conducting 24 disease-focused meetings in five years, FDA moving to next phase of patient interaction under new user fee cycle.
US FDA Planning Another Patient Group To Boost Involvement
Patient Engagement Collaborative expected to invite stakeholders to discuss how patient interaction with FDA can improve.