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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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.
After conducting 24 disease-focused meetings in five years, FDA moving to next phase of patient interaction under new user fee cycle.
Patient Engagement Collaborative expected to invite stakeholders to discuss how patient interaction with FDA can improve.