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

• Date: December 16, 2009
• Source: www.gxpnew.com

SUMMARY: 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This guidance finalizes the draft guidance published on February 3, 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.

DATES: Submit written or electronic comments on agency guidances at any 
time.