FDA Publishes "Assessment of the Use of Patient Experience Data in Regulatory Decision-Making" Report Today, the U.S. Food and Drug Administration (FDA) 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 FDA as part of the implementation of the Cures Act and provides a snapshot of progress to date. FDA contracted with Eastern Research Group, Inc. (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: - How does FDA use patient experience data in regulatory decision-making?
- How do FDA staff, applicants, and external stakeholders characterize (a) use of patient experience data in regulatory decision-making and (b) FDA communication about use of these data?
- What good practices and opportunities for improvement exist for (a) use of patient experience data in regulatory decision-making and (b) FDA communication about use of these data?
The report provides details regarding the methods used to identify, collect, and analyze data for this assessment, results, and key findings. The report includes recommendations to FDA on how to better communicate and expand the use of patient experience data in regulatory decision-making, and to external stakeholders regarding the use of good practices to aid in the acceptance of patient experience data by FDA. FDA will use this report to support its efforts to enhance the use of patient experience data in regulatory decision-making. FDA is committed to incorporating the patient's voice in drug development and evaluation. | 
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