Zdrowie i gospodarka · 09/12/2009

Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." This guidance describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments used to measure treatment benefit in medical product clinical trials. It also provides recommendations on how sponsors can use study results measured by PRO instruments to support claims in approved medical product labeling. This guidance finalizes the draft guidance published on February 3, 2006.