Missing Data Hinders Inclusion Of Patient Experience In Drug Labeling, US FDA Says

Agency staff note hurdles in obtaining evidence outlined in FDA’s patient-focused drug development guidance to support regulatory decision-making.

Patient data — Missing data on trial endpoints can limit drug label claims • Source: Shutterstock

One of the challenges US Food and Drug Administration reviewers face is missing data in sponsor applications, particularly data on trial endpoints needed for a labeling claim.

FDA’s Michelle Campbell, senior clinical analyst for stakeholder engagement and clinical outcomes in the Office of Neuroscience, highlighted this problem...