FDA: Use of patient experience data in regulatory decision-making

The US Food and Drug Administration (FDA) yesterday published a report titled “ Assessment of the Use of Patient Experience Data in Regulatory Decision-Making.”

Section 3004 of the 21st Century Cures Act (Cures Act) requires FDA to report on the use of patient experience data in regulatory decision-making. This is the first such report released by agency as part of the implementation of the Cures Act and provides a snapshot of progress to date.

The FDA contracted with Eastern Research Group (ERG) to conduct this first assessment and to produce the report. ERG assessed document reviews for New Drug Applications (NDAs), Biologics License Applications (BLAs), and efficacy supplements and conducted interviews with FDA staff, applicants, and external stakeholders. The assessment gathered information to answer three questions: