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.
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.
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The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.