Regulatory Update

| 01 February 2010

The US Food and Drug Administration (FDA) released the final Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, in December 2009. Draft guidance was published in February 2006. The document describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments (i.e., a questionnaire plus supporting information and documentation) used to measure treatment benefit or end points in clinical trial studies. The guidance also provides recommendations on how sponsors can use study results measured by PRO instruments to support claims in approved medical product labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their discussions with FDA during the medical product development process, streamline FDA's review of PRO instrument adequacy and provide optimal information about the patient's perspective for use in reaching conclusions about treatment benefit at the time of medical product approval.


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