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Regulatory Focus™ > News Articles > FDA Issues Final Guidance on Patient-Reported Outcome Measures Used to Support Labeling Claims

FDA Issues Final Guidance on Patient-Reported Outcome Measures Used to Support Labeling Claims

Posted 01 April 2010

In December 2009, the US Food and Drug Administration issued Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. In appropriate circumstances, healthcare product manufacturers can rely on patient-reported outcome (PRO) data to support labeling claims. A PRO is a report on a patient's health condition that comes directly from the individual, without amendment or interpretation of the response by a clinician or anyone else.

 

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